cGMP – Design and Development Master Validation Plan (10)

July 15th, 2019 Posted by Requirements Management Tool, Test Management, Validation and Verification 0 thoughts on “cGMP – Design and Development Master Validation Plan (10)”

People in the medical device industry are often wary of the term validation even though they shouldn’t. Validation is using objective evidence and experiment to ensure that a set of requirements are met when testing for product or service usage. Furthermore, as it pertains to device validation. The objective is to match the specifications with user needs and application. Therefore, validation is proof that using a specific process to manufacture a device will meet both device requirement and user demands.

Validation is the building block for verifying the quality of a product. As a result, the product that is tested during validation must represent the final product. According to ISO 13485, companies must keep a record of the product they use during validation.

Validation MVP

In the same way that the design control process starts with a plan, validation must take the same approach.  The plan is often extensive, covering several areas earning the name Validation Master Plan (VMP) or Master Validation Plan (MVP). It is best to always start the validation plan early in the design process. The plan should be able to pinpoint what will help satisfy the criteria like;

  • Methodologies
  • Performance properties
  • Validation activities

Likewise, there should be a review of the validation plan to avoid risk and deficiencies.

“The First Article”

The first article is the common name given to the first set of products. They are either serialized batch or initial batch (Validation batch). In some cases, validation reports help to document the properties of the first articles. Also, there could be a separate first article report. Forgetting to include labeling and packaging as part of the validation process is a common oversight.

It is crucial that companies include packing in their validation plan. Its effect of product performance is enormous and difficult to measure.  Some packaging can give off electrostatic charge or cause the material to leach into a sterile product. Therefore, testing the packaging can help prevent such occurrences. Similarly, the validation plan should include labels. Environmental conditions can cause labels to fail, leaving the product bare and unbranded.

Inclusion of clinal trials in the product validation is optional and depends on the type of product. Nevertheless, there should be some form of clinal evaluation just in case. Also, validation should account for the worst possible scenarios using simulations that mimic the conditions that the product will face. Some possible simulations can test for the following;

  • Vibration and shock
  • Temperature
  • Humidity
  • Other tests will account for either transportation or storage of the product.

Finally, validation should take into account the following customers/users;

  • Operators
  • Patients
  • Caregivers (nurses/doctors)
  • Other relevant parties


Orcanos Master Validation Plan

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CAPA: Corrective and Preventive Actions Introduction Principles – Chapter I

July 7th, 2019 Posted by Requirements Management Tool 0 thoughts on “CAPA: Corrective and Preventive Actions Introduction Principles – Chapter I”

Corrective and Preventive Action (CAPA) is a way to improve the company’s processes. They are a series of actions that eliminate unforeseen events and causes of non-conformities. Likewise, CAPA, as a concept falls under several ISO business standards and Good Manufacturing Practice (cGMP).  The primary focus of CAPA is focusing on the root causes of specified problems and risks. In so doing, it can help ensure that they won’t be a need for either corrective action or preventive action in the future. This article aims to help you understand the CAPA process within a regulated environment.


The outline on the subject of CAPA is as follows;

  •         Background
  •         The current State of CAPA
  •         Process Requirement
  •         Process Analysis
  •         The CAPA status review
  •         Conclusion


Two major forces drive the CAPA system. In the US, there is the Food and Drug Administration, the federal regulations, Title 21 Part 820 Subpart J, and CAPA Section 820.100. Meanwhile, companies in the EU that accept the ISO 13485 standard for the quality system there is the Section 8.5.2 corrective action and Section 8.5.3 preventive action. It is worth mentioning that 820 will be known as 21 CFR 820, and 13485 will be EN ISO 13285:2016. Also, there is not of a difference between the old 13485 standards of 2003 and the updated version of 2013 but there are some changes on the 2016 edition when it comes to CAPA requirement.

It is a requirement for both the US FDA and ISO 13485 that CAPA procedures be documented. In the descriptions for CAPA in both organizations, they both address non-conformities.

Regulatory Confirmation

The eligibility criteria for a CAPA system mandate that a situation of non-conformance or a risk of having it. The common suspects for non-conformance issues are either components, products or something physical. However, processes are also suspect despite being less obvious. Regulations often demand that organizations follow specific processes when collecting or analyzing artifacts. Non-conformities are bound to happen when processes are ignored, and there is no collection of artifacts.

CAPA has two distinct components, namely, corrective action and preventive action. Corrective action is used to address systemic non-conformities when they occur. Meanwhile, preventive actions help to address the risk of non-conformities that are likely to happen. In that sense, an electronic system such as Orcanos must let you conduct traceability to CA/PA activities as well to RISK and its mitigation.  

Image1: Orcanos Traceability from/to CAPA

Only About Compliance?

There are pivotal debates regarding the CAPA system. There is an argument that if there is a systemic non-conformity, then action should be taken to identify why and take action to fix and prevent the occurrence in the future. On the other hand, companies find preventive actions problematic. It is not unusual that companies take precautionary steps frequently in the form of reviews, prototypes and much more. However, rarely do they run the steps through the preventive action process.

Despite CAPA and DR (Design Review) and report topping the list, it is difficult to ascertain the safety and effectiveness of products considering the high rates of recalls. A non-scientific approach to the various findings reveals that there is a lack of understanding when it comes to the CAPA approach. The result leads to a lack of implementation. For example, stating that all CAPA will be closed in 60 days in the CAPA Standard  Operating Procedure (SOP) is wrong. The action further demonstrates a lack of understanding of the CAPA process. Inspectors are left with no choice other than issuing findings to processes that they can’t implement or follow.

Therefore, this article will be highlighting realistic ways to approach the CAPA process. The hope is that it will reduce any form of self-damage when it comes to findings and equip you with tools that will guide the regulatory compliance of your business. Eventually helping you making a choice to move onto some electronic form of system to manage the CAPA complete process.

The Basics of Corrective Action

Corrective Action is the first section of the CAPA. Identification of non-conformities tends to trigger corrective action. Although, the language in 820 when addressing CA is cause for confusion as it stipulates action to eliminate reoccurrence. There will be clarity on the subject further down the line.

The Basics of Preventive Action

Preventive Action (PA) represents the other half of CAPA. It becomes actionable in situations where there is a risk for non-conformities, and no steps are in place to mitigate such risks. IT worth mentioning that while in the 13485 standards, there is a distinction between CA and PA. While in 820, there is no such distinction when it comes to CAPA. 

We stated that PA is a frequent feature as part of a company’s project risk activity. The activities often include design and review for manufacturing, preventive maintenance and much more. However, the challenge is identifying when to apply preventive action.

Key Concept

The inconsistent use of terminologies is to blame for the problems in the findings of the CAPA system. To correct this notion, we will be using some easy to grasp terminologies in the absence of standard definitions.

  • Corrections: They are actions taken to resolve problems like replacing a faulty capacitor in a circuit board. Another example is fixing a software bug that alters the user’s input.
  • Corrective Actions: Actions that helps ensure that a problem will no longer occur. For example, changing your capacitor supplier cause they supply faulty resistors to a more reliable supplier. Alternative, training a programmer on a concept that they made an error while working.
  • Preventive Actions: Actions that will stop a problem from happening. An example is reviewing a capacitor’s rating before use to estimate the likelihood of fault. Alternatively, set up a coding standard that programmers can use to review their code to prevent problems.

Systemic Issues

It would not be efficient to flood the CAPA system with every issue. As an alternative, only system issues should be in the CAPA system. Now, the question becomes, what is a systemic issue? In simple terms, it refers to problems that will keep happening without any intervention. System issues can manifest in the following ways;

  • Quality: Missing procedures in the quality process.
  • Product: Failure that keeps rerepeating.
  • Manufacturing: Out tolerance results that don’t stop.
  • Process: Missing steps or lack of actionable steps.

Non-Systemic Issues

By describing non-systemic issues, we better understand the difference between it and systemic issues. Non-systemic issues are problems that are likely to happen once or possess low reoccurrence probability. When dealing with processes, fallouts are not unusual. Therefore, having fallout that is within the limits of the process makes the problem non-systemic. Checking trends and frequency of a problem occurring is the best way of determining if it is non-systemic. However, if you have a non-systemic and non-conformity problem, the action is required.

Some of the best practices will involve checking the trend of all non-conformities, and assessing non-conformities to determine the disposition. Orcanos eQMS system includes a Non-Conformities eForm that will allow you to report and measure your NCR. 

Systemic Issues Product Examples

Below are a few examples that showcase system issues in products.

  1. Should the door be open, an infusion pump will not prevent free flow. The free flow is a systemic issue as the door opening with a set installation will not stop people from seeing the patient.
  2. Cross-contamination of duodenal scopes is responsible for a spate of infections. The reason is that the scopes were not cleaned properly to prevent infection. The problem might have fallen under non-systemic issues if it happened just once. However, the frequent rate at which the infection keeps occurring makes it a systemic issue.
  3. After several testing, making parts that do not match their corresponding mating part as per specification. The rate at which this error occurs and the fact that it surpasses the process limit makes the error systemic.

Systemic Issues Process Example

Problems can come from other factors like processes rather than the product.

  1. When an audit reveals that the quality system failed to incorporate a CAPA requirement. For example, a means of assessing the effectiveness of corrective action. The problem becomes systemic if the process is already reviewed, approved and documented.
  2. An FDA inspection revealing that a company does not keep a record of customer complaints and then issues them a 483. The problem is systemic if the people responsible for taking the call do not realize that all customer related calls should be recorded.

On our upcoming post about CAPA, we will give more tools and tips about how to improve the handling of the CAPA process and be more effective.

cGMP – Design & Development Review Principles

July 1st, 2019 Posted by Requirements Management Tool 0 thoughts on “cGMP – Design & Development Review Principles”

It is quite essential to have a formal design review process. When designs are made or put in place, it is of utmost importance that they are reviewed. A formal review process will help you critically analyze a design in its entirety.

Design Review

This consists of a documented evaluation of the design. It is a comprehensive and also a very systematic process. A design review possesses the data gotten after the proper examination of a design. In a nutshell, it seeks to also carefully evaluate the adequacy and/or capabilities of the design requirements.

One of the most important reasons why a design review is a must is because it will help to identify the problems in the design. While that is really a plus, it is not its only function as it can also help to implement corrective actions to said problems. Design reviews are usually enforced at a more specific/critical stage of the design. However, there are a few other instances that may warrant a design review.

Uses of a Design Review.

The necessity of a design review cannot be overemphasized and this is because it can be used to achieve the following;

  1. Project Progress – In order to formally determine the progress level of a design project, you will need to conduct a design review.
  2. Provide Feedback – A design review helps to provide a comprehensive analysis of the design. This feedback can be used to generate useful data during the design process.
  3. Notification of Emerging Problems – A design review is still your best bet in discovering problems that may arise in a design project. It serves as a check and balance system during the design process.

Orcanos Design Review System

Factors that Influence the Phases of a Design Review.

There are two major things that directly influence the number of phases in a design review. They include;

  1. The Organization – The organization responsible for the design would usually have their own unique parameters or systems in place when making a design. Depending on the bottlenecks in the design process as per the organization’s procedures, a design may have a single or multiple phases in its design review.
  2. The Complexity of the Product – For a simple product with minimal interfaces, it is possible to have a design review with only a single phase. However, if the product is a complex one, it follows that it would generate more than one phase due to its numerous interfaces and sub-systems.

Design Freeze.

This simply refers to a stage in the design review process where design cannot accommodate any more changes. However, this stage will only allow changes if a formal change is made to the design.

Orcanos Freezing Mechisim

Collection of Reviews.

A diverse number of reviewers are typically required when conducting a design review. When orchestrating a review, it should be a collective one where the reviewers are both in-house and external. This would allow for an unbiased examination and final judgment on the design. These reviewers should be in fields such as;

  1. Electrical engineers; a reviewer with a good understanding of electrical appliances and how they work will be essential to a team of reviewers.
  2. Software engineering; one with expertise in this field would be a viable option for a review team.
  3. Manufacturing; this goes without saying as whatever is being designed will eventually need to be manufactured. 
  4. Quality assurance; someone needs to be able to check the quality status of the design.
  5. Regulatory affairs; guidelines must be followed and the necessary rules adhered to and this is where someone with such skill comes in.
  6. Mechanical engineering; this reviewer will be capable of understanding the mechanics of the product.

Others include reviewers in marketing and clinical and also customers (either through direct or indirect participation). Lastly, an important member of the team is the independent reviewer who bears no direct responsibility but has a technical understanding of the device and brings a fresh perspective to the table. 

Systematic Process.

We have said that the design review follows a systematic process that allows for the documentation of the progress of the design. Should there be any need to update the design, the new changes would have to be effected in the design input document. Depending on the level of changes made, there may also be a need to redesign the product or simply change the labeling.


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OrcaMotive ASPICE Event Madrid Spain 2019

June 18th, 2019 Posted by Requirements Management Tool 0 thoughts on “OrcaMotive ASPICE Event Madrid Spain 2019”



Tel: +972-3-537-2561

OrcaMotive Event – Madrid Spain 2019

¡Usted está invitado a nuestro evento OrcaMotive! Orcanos es un proveedor líder en el ciclo completo de gestión de cumplimiento para la industria automotriz.

Este evento presenta consejos y tecnología para cumplir con los requisitos de cumplimiento y regulaciones de la industria automotriz. El mismo discutirá cómo actualizar su organización respecto a los requisitos de ASPICE e ISO 26262 utilizando tecnología y herramientas avanzadas.

You are invited to our OrcaMotive FREE event! Orcanos is a leading vendor in the compliance lifecycle management for the Automotive industry.

This event showcases tips and technology to meet the compliance and regulation requirements for the automotive industry. The event will discuss how to bring your organization up to speed with ASPICE and ISO 26262 requirements using advanced technology and tools.


 Wednesday, 17th July 2019 at 13:00 PM

 Paseo de la Castellana 43, 28046, Madrid Spain
Mr. Benny Prujan | Director, Program & Functional Safety Manager |  Valens Semiconductor, Israel

Functional Safety Introduction

Mr. Rami Azulay | Head of Sales and Marketing | Orcanos, Israel

Quality system requirement and implementation for ASPICE compliance requirements

Copyright © 2019, @ All Rights Reserved. |

cGMP – Medical Equipment Calibration – How it affect our success – ISO 13485:2016

June 17th, 2019 Posted by e-GMP, Requirements Management, Validation and Verification 0 thoughts on “cGMP – Medical Equipment Calibration – How it affect our success – ISO 13485:2016”

Calibration is considered as an essential procedure for any equipment and device, in order to maintain and improve its accuracy and precision. Calibration is the process, in which equipment under test is compared with some other standard equipment, in order to understand the accuracy of the one being produced. The calibration of medical equipment is also based on the same principle.

Medical equipment calibration is essential to the success of the product, the demand for calibration planning system is increasing, owing to various factors, such as rising number of hospitals, increasing environmental regulations, and rising customer focus towards quality and precision. The purpose of this article is to help identify both the current and future of calibration in the medical device market.

Medical device calibration has two sections, the service types, and the equipment types. The equipment types have a market in the following segments;


  • Infusion pumps
  • Fetal monitors
  • Ventilators
  • Imaging equipment
  • Vital sign monitors
  • Cardiovascular monitors etc.


Meanwhile, the service types have three major markets namely;

  • In-house Calibration: The Professional personnel of the company will perform the calibration. The staffs are mainly from the production line.
  • Third Party Calibration Services: Other professionals outside the company will perform the calibration for a fee.
  • OEM Calibration Services: The owner of the service will need to set up plans and notification ahead of time.


Out of the all above devices, The medical device producers of imaging equipment requires calibration services are the largest demand. Although, there are expectations that cardiovascular monitors will keep growing at the highest growth rate to match demands.

Increasing focus of customers on the quality, rising growing need for more control on the calibration planning and documentation due to strict compliance environment which are key factors expected to drive the growth of this demand.

The critical factors in driving the demands for cardiovascular monitors include:

  1. Customers are focusing on quality.
  2. The need to control calibration planning.
  3. Strict compliance requires documentation.
  4. A rise in product recall.


Reports from the FDA in the US show that in the past decade, product recalls has grown from 763 to 3202 between 2009 and 2017.

These recalls were observed due to software design failure, component and material issues and packaging and labeling. Hence, such frequent product recall affects the company’s reputation and thus, the companies are offering a strong emphasis on the calibration of their products before and after commercialization.

This fact is considered as an important growth propeller of this demand by the medical device manufacturers market. In addition, rising demand for third party and in-house calibration services is another important driver for the need of calibration planning system such as Orcanos eQMS.

What could affect the implementation of Calibration system?

Some of the crucial factors include;

  • High Capital
  • The use of modular instrumentation
  • Regional and local companies dominating the market


Medical equipment calibration services are segmented in areas such as North America, Europe, Asia-Pacific and Rest of the World (RoW).

Presently, we see the European region is the largest market in the world, owing to extensive R&D practices by the industry, a large number of local and regional players and rapidly growing medical and healthcare infrastructure.

However, Asia-Pacific region is expected to be the fastest growing market during the forecast period 2019 – 2025. This growth is driven by rising demand for good quality services, steadily increasing medical infrastructure and rising government regulations.

The purpose of this article is to help identify both the current and future of calibration in the medical device market.

Orcanos provide for these players a greater potential by collaborating with the vendor directly over Orcanos eQMS cloud system to plan and execute the calibration program.

Some of the global service players include Fluke Biomedical, Tektronix, Inc., JPen Medical Ltd., NS Medical Systems and Biomed Technologies, Inc. amongst others. However, these companies have to face stiff competition from various players operating at the regional level and hence; collaboration or acquisition of cloud system is considered as an important strategy for the players to grow in this market.

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cGMP – Design and Development Outputs (SwRS-MecRS-HwRS-FwRS) – ISO 13485:2016 (8) Clause 7

June 16th, 2019 Posted by e-GMP, Requirements Management, Validation and Verification 0 thoughts on “cGMP – Design and Development Outputs (SwRS-MecRS-HwRS-FwRS) – ISO 13485:2016 (8) Clause 7”

In the same manner that we have design and development input. We also have design and development output. The result of satisfying the criteria for design input is the design output.  The output will possess risk assessment for the following ;

  • Assembly drawings
  • The specification for raw materials and components
  • Design and process
  • Instruction for installation and service
  • Guideline for the assembly process
  • Specification for labeling and packaging
  • Source code and technical files
  • Biocompatibility studies
  • Results of verification activity
  • Validation activities such as sterility, reliability testing or shelf-life studies and shipping.


The design and development output is also known as the first realized product. Depending on the type of product. It could be the first of several lines of assemblies or the first batch of products manufactured. The initial set of the first realized product must undergo evaluation checks. The checks will ensure that the design output requirement is met. Likewise, there will be serial number checks to ensure there is consistency in the process.

Orcanos ALM provides all the tools you need for complete coverage of the design outputs both from the product definition but as well from the change control as risk management according to ISO 14971:2012 with full traceability and impacts analysis tools, all in the same tool.



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cGMP – Design Inputs (URS-FRS-MRS-ERS) – ISO 13485:2016 (7) Clause 7

May 30th, 2019 Posted by e-GMP, Requirements Management, Standards and Regulations 0 thoughts on “cGMP – Design Inputs (URS-FRS-MRS-ERS) – ISO 13485:2016 (7) Clause 7”

We expect that the Design & Development Plan be a written and reviewed document. Similarly, the Design Inputs also needs to be a controlled document. In practice, the design input document is created alongside the DDP simultaneously. However, before we start to analyze the design input, we should take a look at User Requirement Specifications (URS) or Customer Related Processes (see ISO 13485:2016 Chapter 7.2).

The focus of the URS should be on the customer experience. In other words, it should be a list of what the user desires rather than a list of requirements. Also, the list should not have solutions alongside it unless the solution satisfies the requirement of what the user wants to achieve using the product. Likewise, the URS should also include answers on what the customer experiences. In the medical device industry, the demands of the users should be considered from two perspectives namely;

  1.      As a patient.
  2.      As the device operator.

The moment the needs of the user is identified, the device designers have to translate those needs into the design input forms. Although the job is primarily that of the device engineer, inputs from crucial personnel in production, marketing, service, and others should be added as needed. Design engineers should strive to eliminate ambiguity in the design input process to reduce the level if inaccurate assumption. One of the effective ways to avoid false assumptions is to exclude design solutions from the design inputs unless the solution is part of the design. For example, let say a user requirement is; the device must have a foot switch to trigger operation. A suitable alternative would be not to specify a foot switch, rather have the requirement stipulate the need for a hand free operation for the device.

Design Input Categories

Using the User Requirement Specification, one can easily generate several input requirements documents. Input Requirements often fall into three categories namely;

  • The Functional Requirements (FRS): This requirement specifies the capabilities of the devices, its operations as well as its input and output characteristics.
  • Performance Requirement (PR): It covers the device behavior during use, and some of the behaviors can include; precision, ranges of quantitation accuracy, operational environmental ranges, and other performances.
  • Interface Requirement (IR): All interface requirements should be specified. Interface requirements can be either external or internal. However, all specifics relating to the interface should be listed.  External interfaces can be in the form of patient/product interface, external communication interface, and operation/product interface. Meanwhile, the internal interface can be software/hardware and communication interface. Each interface requires a review to ensure that the system works well together.

The documentation for each requirement often depends on the product and the organization. Although, almost all organization have functional requirement documentation or documentation that directly addresses design input requirements (DIR). Sometimes there are separate documents to capture specific requirements of the document such as a Mechanical Requirement Specification (MRS). Another example is the Electrical Requirement Specification (ERS) that are created within the sections or either the DIR or FRS documentation, Orcanos ALM system support over 58 different types of requirements and can be expended to more as needed.

Other requirements that deserve consideration are safety and regulatory requirement. We mustn’t forget the requirements for applicable risk management inputs.

Adequate Time

There should always be enough time to allow for the development of the Design Input Requirement (DIR). Each requirement should be ;

  •         Unambiguous
  •         Quantitative
  •         Contain expected tolerance.

The environmental conditions for optimal performance of the medical device and environmental specification for storage of the device should be stated. As much as is possible, organizations should try to capitalize on the standards set by the industry for each product. Nevertheless, the standards should be reviewed to ensure they cover and satisfy the design input requirements. A popular example is the referencing of ASTM D40169 for performance testing of shipping containers and systems as it relates to verifying the method of testing and packaging conditions. The standard sometimes might not cover the acceptance criteria like in this instance, and if such provision is left out of the DIR, the design input requirement will be incomplete.

It is expected that over the corse of product development, the design input requirement will change. For this reason, the change control will play a vital role in ensuring that the changes are reviewed based on their impact on other design input requirements, Orcanos traceability tools also includes integrated suspicious indication feature which proactively alerts on such possible impact. It is not unusual that a change in one requirement would affect another design input requirement. For more information see related links

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cGMP – Design & Development Plan (General ) – ISO 13485:2016 (5) Clause 7

May 23rd, 2019 Posted by e-GMP, Requirements Management, Standards and Regulations 0 thoughts on “cGMP – Design & Development Plan (General ) – ISO 13485:2016 (5) Clause 7”

Most device manufacturers find the concept of design control confusing. However, design control is better understood now as a result of better structure. The foundation for every product quality is the design process. Similar to a building, the better the foundation, the lesser the risk of collapse. In terms of design, the final product is dependent on the design process.

The design control process can be implemented for medical devices, manufacturing equipment, and operation, and software systems can make use of a similar process.

Below is a diagram of the waterfall system of design.

Waterfall Design System


The diagram depicts a simplistic version of an approved FDA control guidance. The design is typically more complicated due to several elements developing at the same rate. However, the waterfall diagram does serve the purpose of aiding understanding of the operations of the design process.

Common Mistakes in Design Development

One of the prominent mistakes to make is to assume that design control is the same thing as the development process. Although, the development process is a vital part of design control, a more accurate description for design control is to envision it as a lifecycle.

By picturing design control as a lifecycle doesn’t mean that design control will cover requirement for feasibility or marketing. While these processes are vital to the product development process, regulations are in place to monitor product design rather than concern itself with the success of the product in the market. Regulations are more about the safety of the design product instead of the general welfare of the business.

It is important to differentiate between the design input requirement and the marketing requirement and feasibility studies. The design input requirement is also known as the product concept document.

Document Approval

A common problem that most organization face is the approval of documents. There is always a reluctance to approve product design documents as they have to create a room for change and improvement on the document. However, by maintaining control over the document, the approval process tends to become tedious. The goal of control is not to restrict flexibility but to ensure that every phase of the design process is sync, especially when dealing with cross-functional teams.

Typically, approval can be given for revision 1 of a document with To-Be-Determined (TBD) values in certain sections. Meanwhile, teams can start preliminary drafts for the second revision of the document. Subsequent sections will address the core elements of the design control process. However, implementation of the process will depend on the following;

  • The maturity of the company.
  • Product complexity.

It is worth noting that most organizations prefer to breakdown these processes into individual (SOPs). But, it is possible to have a document that covers all the requirement of several elements of the design and development control process.

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cGMP – Design & Development Plan (DDP) – ISO 13485:2016(6) Clause 7

May 11th, 2019 Posted by Requirements Management Tool 0 thoughts on “cGMP – Design & Development Plan (DDP) – ISO 13485:2016(6) Clause 7”

Defining the stages of design and reviewing every stage of the design process is one of the requirements of ISO 13485 Section 7.3.5 for design and development. The task of identifying and reviewing designs at every stage is accomplished using the design control SOP. Once the User Requirement and Specification (URS) for a medical device is established, the next step in the planning stage is the Design and Development Plan (DDP).

Every product has its unique design and development plan, and they appear in the products documentation as either DDP or D&DP.  There are two main things to consider when creating a Design and Development Plan for a medical device.

  1.      Draft the plan and approve it using the design control system.
  2.      At crucial moments in the design stages, update and review the plan.


What is in the DDP

The Design and Development plan will differ with the complexity of each product as well as with the organization that produces them. For a simple product, the DDP can be in the form of a basic flow chart. However, with a more complex product, the design and Development plan will be in the form of a well-detailed Gantt chart.


The first thing that the DDP should cover is the objectives and goals for the product. This will help clarify the purpose of designing the product and its functions. Next, the DDP should note the various departments involved in the designing of the product and their roles. In addition to that, information on contractors or sub-contractors that will be contributing to the project. The assignment of responsibility as well as documenting them is vital to the success of the product design. Likewise, collaborations and shared responsibility should be elaborately defined to eliminate ambiguity or confusion. This is vital if the project involves multiple teams or departs.

The design and development plan should also have a breakdown of tasks alongside the people/team responsible for them. The task breakdown should include the following;

  • The time duration for the product design.
  • The resources that would make the project a success.
  • Individual responsibility for set tasks.
  • Allocation of resources.
  • Criteria for fulfilling each task
  • Collaboration points and the teams are collaborating on a specific task.

The task breakdown will help optimize the time it takes to complete the product and get it ready for the market. There should be a report documenting the target for each task, and it should have tests and studies that prove that the product is safe for use. Some of the tests and studies to consider are as follows;

  • Shipping studies
  • Biocompatibility testing
  • Validation of sterilization processes
  • Non-Clinical animal studies
  • Electromagnetic Field (EMF) Interference studies
  • Mean-time-to-failure-studies
  • Clinical evaluations


The tests and studies to be conducted will depend on the type of product design and the function of that product.

Another set of criteria that should be present in the design and development plan is what to expect from the activities of design transfer, and how to monitor what is being transferred. The expected result from the design process should also be weighed against the process input.

Problem with Design and Development plan

The biggest problem that comes with a DDP is the way the project manager tends to overestimate the product design timeline. Usually, such a problem arises with a lack of experience, lack of optimization and flexibility to the plan, and trying to work backward. It is important that tasks are completed on time, but there should be room for updates to account for unforeseen circumstances in the design process.

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cGMP – Customer Related Processes and Requirements – ISO 13485:2016(4) Clauses 7

May 4th, 2019 Posted by Requirements Management Tool 0 thoughts on “cGMP – Customer Related Processes and Requirements – ISO 13485:2016(4) Clauses 7”


The purpose of Customer Related processes as stipulated in the ISO 13485:2016, is to make sure that companies keep to a high standard when it comes to the products and services they offer to customers. In other words, it is a way of ensuring that the customer is the focus of the company and its product.

What the ISO 13485:2016 is hoping to achieve is a document that outlines an established User Requirement. The practice which started with the software industry helped to ensure that products meet the desired outcome of the end-users. Companies in today’s world, are concerned with how the user interacts and experiences the product, rather than what they need in their design process. Hence, abandoning the need for User Requirement for User Experience.

Apple products are an example of how design focuses on user experience instead of user requirement. Henry Ford, the famous founder of Ford Motors, made a quote that reveals a unique flaw with user requirement. He said that if he had been opportune to ask people what they required, they would have responded that they needed faster horses rather than cars.

While the software industry is embracing the concept of user experience, the medical device industry is still relying on user requirement. Although there is hope that the medical device sector will get there, we will be addressing User Requirement Specification (URS) as a part of the ISO 13485 clauses for customer-related processes and requirements.

Considerations Demands by ISO 13485 for Product Requirement

One of the most vital requirements for the product, as stipulated in the ISO 13485 clause, is the requirement for both delivery and post-delivery of products. There have been cases where companies failed to supply requirement for products as they relate to the installation, maintenance, training, packaging, calibration, and servicing. The ISO 13485 does mandate that these requirements be available and if they aren’t, they should be a justified reason for their absence.

Typically, not all products require all parts of the requirements. For example, the User Requirement Specification (URS) for a disposable device might only contain a section that justifies why there is no product requirement for calibration, servicing, maintenance and training. Additionally, another critical information stated in ISO 13485 is the fact that requirements not mentioned but needed for the product use will be identified. The stipulation helps to address the intent for consideration for product requirement during usage.

A disposable contact lens is an ideal example in clarifying implied consideration for the product requirement. Let’s say that the average shelf life for the contacts is 2 years as stipulated in the product requirement. However, the contact usage life cycle after the customer opens the seal is not accounted for in the requirement. Hence, should a customer use the lens for a week consistently before discarding it, while testing under such conditions has no to be done, implied product requirements means that the company has violated a requirement under the ISO 13485. Likewise, companies have to fulfill all applicable requirement such as the region and market for the product to best determine which product requirement to follow and note them in the product requirement document. In totality, even though the requirements may be specified or implied, they have to be met.

Product Requirement Review before commitment

This section of the ISO 13845 mandates the review of the product requirement long before the product gets to the customer. The review should cover the following;

  • The documentation and definition of product requirements.
  • The fulfillment of all applicable regulatory requirement.
  • Updates on contract requirements that exist in previous product requirements.
  • The capability of companies to satisfy the requirement.
  • Planning and execution of required training.

All the review requires are pretty standard and can be met easily. The design and development team is responsible for the generation, design, and review of a URS document. Similar to every other report, the User Require Specification document will be revised for the entire length of a product. It is crucial that recisions be tracked and noted and more critical, changing numbering each revision or updates should be avoided as references to previous updates is a possibility. Similarly, with each new update and stage in the development of a product, the URS should be revised and updated. The same principle applies to contract updates for customer-based products as changes that exist with previous requirements need to be addressed.


Communication is the last major part of customer related process under ISO13485 and must be appropriately managed. All forms of communications with customers to be the individual or commercial customer requires careful consideration. A requirement that covers all forms and ways in which communications with customers are performed must be made available. The requirement covers; inquiries about orders, contracts and their amendments, product information, advisory notes, and feedback processes including complaints.

Also, there needs to be a way to categories which customer related communication that should be submitted to regulatory organizations alongside a scheduled time and system for the process. The communication that organization submits will vary with where they market their product and the industry category of their product.


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