Webinar – FDA Recommended on the practical application of ISO 14971

March 14th, 2021 Posted by Requirements Management Tool 0 thoughts on “Webinar – FDA Recommended on the practical application of ISO 14971”

Description: Learn from world expert Mr. Bijan Elahi; FDA recognized, what to do to be compliant with ISO 14971:2019. Understand the nature of risk and different risk types. Gain insights on how to leverage risk management to get your medical devices to the market faster, safer, and more smoothly.

Webinar | Build a Document Control System to ensure ISO and FDA compliance in 72 hours

February 15th, 2021 Posted by Requirements Management Tool 0 thoughts on “Webinar | Build a Document Control System to ensure ISO and FDA compliance in 72 hours”

Many companies implement an electronic document control system, for meeting the regulatory requirements given by the FDA, CE, and other bodies. In this session, you will see how easy it is to do the transition into a digital system and at the same time ensure that you meet ISO 13485 requirements.


Why Product Recalls Help Us To Expect The Unexpected

December 27th, 2020 Posted by Requirements Management Tool 0 thoughts on “Why Product Recalls Help Us To Expect The Unexpected”

With a global pandemic still generating daily headlines, there is a defined need for quality management professionals to keep their eye on the ball, both in terms of the product lifecycle and the recall possibilities that may damage brand reputation in the near future.

Product recalls are an unfortunate part of the quality landscape, but companies that don’t put the right strategies in place from day one are likely to keep repeating the same mistakes. For the most part, the average consumer is blissfully unaware of when a product is recalled or has quality-related issues, but that doesn’t alleviate the duty of care that every company should have to its end user. 

This lack of actual awareness can alleviate some of the pressure that a brand faces when a poor quality product is identified through either a regulatory process or internal investigation, but the need for a culture of quality should be present throughout.

Product recalls are not something that can be planned for, but understanding that they may be both part of your present and future business optimization strategies is a critical part of the quality management process. This becomes even more clear when you look at data generated in the year to date.

The latest quarterly report from recall solution provider Stericycle notes that the ongoing challenges that the pandemic has created are only part of the puzzle. Product recalls can come from a variety of sources, but companies need to make sure that they have all of their ducks in a row when a recall is required.

According to Stericycle’s Q3 2020 Recall Index, the combination of the holiday season and the continued surging of the virus will make not only the end of the year difficult to manage in terms of product safety but also the first financial quarter of 2021. 

The problem that most companies will face, the report said, is it is almost impossible to predict what will happen if an economic shutdown contributes to the overall customer landscape. In addition, there is a defined need to manage risk during the immediate aftermath of COVID-19, albeit that there is a better understanding now of its impact on elements such as the supply chain then there was back in March or April.

“In reality, no matter your industry, recalls are only a fraction of the in-market remediation activities you deal with every day,” said Stericycle’s vice president of crisis solutions Chris Harvey, in a blog post. “As the regulatory landscape evolves, customer expectations grow, and plaintiffs’ attorneys seek vulnerable targets, you must adapt to protect your reputation and your ability to grow your business.”

Product recalls damage brand reputation

Stericycle has been collecting and collating product recall data for several years. As a result, the quarterly report offers a snapshot of five defined product categories – Consumer Products, Pharmaceuticals, Medical Devices, Food and Beverage, and Automotive. Each one of these sections takes a deeper dive into what factors accounted for recalls in the last financial quarter and the number of units or products affected.

For the purposes of this blog post, we will be concentrating on three categories – Medical Devices, Pharmaceuticals and Automotive.

The full report can be accessed here but there are defined “trends” in each category that give a taste of not only the potential quality pain points but also where companies should focus their attention.

With that in mind, the most prominent recall highlights for our three chosen categories are as follows:

Medical Device

  • Medical devices recalls dropped to a six-quarter low, with 242 reported events in Q3 2020 – a 29 percent drop from Q2. However, the quarterly average for 2020 is still higher than at the same time in 2019.
  • Software was (once again) the top reason for product recalls. For the 17th time in 18th consecutive quarters, software issues were cited as the problem, accounting for 20.7 percent of events and 21.4 percent of units.Average number of units per recall was 901,833.
  • Total number of recalled units fell by 21.9 percent in Q3, from 29.4 million to 22.9 million. This represented the lowest quarterly number in 2020. 
  • Around 87.2 percent of all product recalls were distributed nationwide. From a global perspective, 55.4 percent of U.S. FDA recalls were shipped to international customers.
  • Quality concerns were cited as another top cause for recalls, with 6.2 million units impacted by poor quality.
  • October was the busiest month for medical device recalls: the month saw 77 recalls in total, impacting 31 million units and bringing the average size of an October recall to around 408,000 units. The leading cause of recalls was a parts issue (15 events), with quality concerns and mislabeling generating 12 and 10 recalls, respectively 


  • Recall activity returned to pre-COVID-19 levels in Q3, hitting 100 events – an increase of 49.3 percent. This milestone was the first time since Q4 2018 that 100+ events had been recorded. Affected units also doubled to around 92.7 percent.
  • Nearly a quarter of all impacted units achieved a class 1 severity level, totalling 7.8 million units. 19 events fell into this category.
  • Total number of recall events in 2020 to date is 260 (around 87 events per quarter). By contrast, there were 336 recalls in the whole of 2019.
  • cGMP deviations were responsible for 29 percent of all recalls, impacting 8 million units. However, quality concerns accounted for the recall of 8.1 million units, around 24.1 percent. It should be noted that one recall was the cause of these quality concerns, with 7.7 million units impacted
  • 83 percent of recalls were distributed nationwide. On the plus side, only 5 percent of affected products had international distribution. 
  • 85 companies initiated recalls, nine of which had more than one event.
  • Average size of a recall in Q3 was 338,000 units, although October (again) was significantly higher – the average recall size was 851,000 during this month
  • Product recalls were not the sole reason that the FDA issued warning letters – in September, the agency sent letters to 17 website operators, operating in China, India, New Zealand, Iceland, Pakistan and the U.S. All of these warning letters related to the illegal importation and sale of unapproved opioids.


  • Recall activity dropped by 23.5 percent from Q2, with recalls totaling 156 events. This is the lowest number since Q1 2013.
  • The average number of recalled units also dropped in Q3 – around 34,000 per event. This is the lowest level since Q2 2019, but there is an expectation that planned investigations into seat belts and lithium-ion batteries will see an increase in recall activity in 2021.
  • Equipment was the top cause for NHTSA recalls, accounting for 17.9 percent and topping the table for 13 out of the last 14 quarters. Service brakes were the main culprit, generating 27.4 percent (1.4 million) of all recalls. . 
  • Automobile recalls continue to lead the way, with 140 recall events relating to this category of vehicle. Three recalls were tire-related, while 13 were traced back to equipment.

The Stericycle index is built on cumulative data, and the quarterly report tracks the data from a variety of sources that include but is not limited to the four primary federal agencies that are responsible for monitoring and (in some cases) initiating product recalls in the United States only. Recall information from other countries or non-U.S. regulatory agencies is not included in this report.

Each of the four agencies – the Consumer Product Safety Commission (CPSC), the Food and Drug Administration (FDA), the Food Safety and Inspection Service (FSIS), and the National Highway Traffic Safety Administration (NHTSA) – produce recall announcements on a regular basis and every agency allocates its own criteria in terms of enforcement, incident reporting and the recall process itself.

Quality matters at every stage of the product lifecycle

As you might expect from a report that shines a light on the problems as opposed to the solutions, the questions that it generates are more likely to be directed at how these recalls impact brand reputation, consumer confidence and the product lifecycle itself. To its credit, Stericycle rarely names or shames the most egregious offenders, but the product quality issues it raises are ones that should be on the radar for companies in each of our identified categories.

Medical devices have come under increased scrutiny in recent months, not least of which is the fact that there was an increased demand for products such as ventilators, face masks and personal protective equipment (PPE). The apparent lack of the latter in some hospitals generated negative headlines and led some healthcare providers to seek alternatives from other markets that may not have the same levels of required regulatory compliance and application lifecycle or quality management systems.

The pharma and automotive industries, for example, also need to maintain a focus on quality, as both of these sectors are – irrespective of COVID-19, it seems – reportedly facing the same sorts of problems every quarter, Stericycle says. 

Some of those issues can be linked to regulatory compliance, but the pharma sector has had a long-standing battle with its supply chain and the consensus is that this is unlikely to get better any time soon. That conflict could be pulled further into the spotlight as the pandemic lingers, even more so when you consider that the FDA – under the watchful eye of the Trump Administration’s “Operation Warp Speed” – deals with the potential requirements of a change in government oversight from January 2021.

By the same token, automobile manufacturers are still recalling vehicles due to failures in core components – airbags, seat belts, to name just two. The reason for this is quite simple; most components are produced by a handful of companies – original equipment manufacturers – that supply the entire industry and that makes it difficult to track down problems until they become something that needs to be fixed.

One element in the product lifecycle for all of these identified industries remains clear. 

Recalls will continue and they will not decrease while business optimization tools such as quality management and adherence to good manufacturing principles are overlooked in favor of speed to market and a need to maintain brand visibility. If the last few months have taught us anything, it is that while you need to expect the unexpected, pushing forward with a flawed product is not a viable option. 

Ultimately, this is an imperfect strategy and companies must think very carefully about whether this is the path they want to take. At the end of the day, a commitment to quality should be the bare minimum for any industry, even more so when the average person is the one that will be impacted by a product recall.

Orcanos does not believe that a culture of quality should vary between industry sectors and company size. Since our formation in 2005, we have consistently focused on alleviating the business-related pressures that occur within the product lifecycle and the quality management process itself.

Our software features built-in best practices and an end user experience that ensures that all the required boxes are ticked before the product enters the market. We know that quality matters, and our solutions have been designed with that as one of the guiding principles.

To find out how Orcanos can help your company on its quality journey, contact us for a demo.

Orcanos Integration with Zapier

August 7th, 2020 Posted by Software Lifecycle Management 0 thoughts on “Orcanos Integration with Zapier”

We’re really excited to announce our coming integration with Zapier, which brings the full power of Orcanos to more than 2000 applications. You will be able to easily link Orcanos work items such as defects, requirements, and tasks to Jira, Google Sheets, Github, Salesforce, Slack, and many other apps, and trigger actions on specific events such as work item update in your Orcanos account, the test fails, new discussion, etc.

No programming skills required!

What is Zapier

Zapier is a popular website that allows you to easily connect two apps (or web services) together and send data between them, by creating some really convenient flow automation, called “zaps”. Zapier currently supports over 750 different web services and apps. You can open a free account to start with, and create your first ZAP within minutes.

Zapier allows you to define actions and triggers.

  • Actions – such as Add/update work item in Orcanos on 3rd party app triggers
  • Triggers – such as work items added or updated in Orcanos will trigger actions on 3r party apps in Zapier

Each integration is called ZAP, and you can define multiple ZAPS.

Zap example: On each bug creation in Orcanos – add a bug in Jira

Orcanos ALM Integration

So, mostly the Orcanos-Zapier ALM integrations will focus on other ALM tools such as Jira, Team Foundation Server, etc.

As Orcanos provides an All-in-one ALM and Quality Management repository, it provides everything for the R&D team. But for those who don’t use Orcanos, the ALM integrating with commonly used tools like Jira makes Orcanos ALM much more powerful. It enables combining regulated tasks related to quality management, electronic signatures, document control, and so on, with non-regulated tasks such as development tasks, Agile SCRUM, etc.

Try to create Zap Application from the above link and let us know if you need any support to do create your first ZAP.

Orcanos Next Jira Integration Webinar:

Related Posts: Zapier Integration, Jira…


Why the FDA Increase Software Classification from Moderate LOC to Major LOC?

August 6th, 2020 Posted by Requirements Management Tool 0 thoughts on “Why the FDA Increase Software Classification from Moderate LOC to Major LOC?”

From our advisory board member Mr. Mike Zeevi

Dear all,

These are very trying times and we are trying our best to keep it together. This year, as you can understand, has been quieter than previous years, in terms of updates to the software from a regulatory and quality perspective. I have done my due diligence and have prepared this update, even though it is not as jumping as previous updates.

I am sending an update on software development standards and good practices as I have done in the past.  Hopefully, this will give you new insights on how to relate to some of the issues happening in the regulatory/quality/technical field.

Life is becoming more difficult for the software developer. More recalls; tougher standards.

There are issues that are facts and there are issues that are opinions. Please try to relate to them accordingly.

Due to the corona emergency measures, it may seem that the level of software for submissions to the FDA for software has decreased, but it hasn’t. The FDA is returning more and more projects that were originally classified as Moderate LOC as Major LOC, with all of its implications.

More and more questions are being asked concerning cybersecurity, even though the FDA has not moved forward yet with the new draft guidance for cybersecurity. This is due to the corona wards now transmitting all patient information outside the ward to cut down on the contact with the corona patients.

We have entered a new world where virtual meetings and virtual audits are the norms. You may ask if this makes life easier or harder. The answer is yes.

Please pass this onto all colleagues and compatriots. If there are any questions or comments, please feel free to contact me. If any receiving this indirectly wants to get onto the distribution list, please contact me.

A copy of the attached document is found on our website: www.softquest.co.il under Updates.


GET THE FULL ARTICLE: Software Update 30Jun2020

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GDocP (01) – Everything you wanted to know about GDocP

July 18th, 2020 Posted by Requirements Management Tool 0 thoughts on “GDocP (01) – Everything you wanted to know about GDocP”

Meeting FDA Requirements?

We will be addressing documentation as it relates to medical devices, processes, and products. With our articles over the next couple of weeks, you will have an understanding of the right way to adhere to Good Documentation Practices (GDocP) for all things relating to life sciences products such as medical devices, automotive, and substances. You can access our detailed explanation on the subject by following this series. The device/products/substances covered will address consumption for LifeScience in general.

Good Documentation Practice

Some of the areas we will be covering include;

  • Engineering (R&D)
  • Validation
  • Testing
  • Distribution
  • Manufacturing
  • Storage and
  • Holding

With our guidance on the right techniques and tools, you should be able to create documents that are easy to understand, traceable, and consistent.

It is worth noting that the techniques shared in these series are a combination of existing guidelines, legislative regulations from governing organizations, and acceptable industry best practices.

What will you learn in these series?

  1. Know why Good documentation is crucial to FDA regulations or other bodies.
  2. The importance of GDocP and why you should understand it.
  3. Educate members of your team on the right and wrong things regarding documentation.
  4. Apply the knowledge to your daily operations.
  5. Gain confidence in your ability to produce high-quality documents.

Who should learn about GDocP?

Anyone or professional that is responsible for documentation as it pertains to medical products or testing in a manufacturing capacity. 

Areas of focus

We will be focusing on Design Input/Output Requirements Test and Test results as part of GDocP in the following areas;

  • All levels of Engineering Specifications
  • Protocol Generation
  • Legal Factors
  • Costly Errors
  • Protocol Execution
  • Attachments
  • Accountability
  • Variable Data
  • Units of Measurement
  • Calculations or Formulas
  • Rules of Thumbs
  • Oops and Uh-Ohs
  • Expected Results
  • Redline the Changes

At the end of these series, it is our belief that you gain valuable skills in generating good documents for all your medical products, processes, and substances.

ISO 13485:2016 Sec. 8.5.2 – Corrective Action Adverse Effect

July 14th, 2020 Posted by Requirements Management Tool 0 thoughts on “ISO 13485:2016 Sec. 8.5.2 – Corrective Action Adverse Effect”

Quoting ISO 13485:2016

“The organization shall document a procedure to define requirements for: e) verifying that the corrective action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device…”

Orcanos CAPA Corrective Action (CA) offers the ability to refer to each part of the above requirement and to manage each corrective action in respect to the Adverse Effect it may have on the device in terms of:

  1. Regulatory Requirements
  2. Safety
  3. Performance


July 13th, 2020 Posted by Requirements Management Tool 0 thoughts on “SERVICING ACTIVITIES vs. COMPLIANT (ISO 13485 Chapter 7)”

Service activities are similar to Installation or Assembly services. However, some devices or equipment do not require servicing, they are often tagged as disposable devices. Nevertheless, should a device require servicing, then it is imperative that it should be stated in the quality manual.


While disposable devices can be described as an exclusion in the quality manual, devices that require servicing should have clearly stated procedural guidelines on its service activities.


Now, with each servicing, a record needs to be created detailing the nature of the service. Likewise, the installation records need to be updated accordingly. Also, information on tests, calibration, or inspection are to be noted. Very similar to the production of the device for the first time, a Device History Record (DHR) record is being logged for each product serial number. 


Orcanos eQMS system grants you the ability to record both the installation and the production history record of the device, with a strong link to the procedures and processes and supplier qualification processes. 


Standard procedure dictates that there be data testing before and after servicing and the process be documented. Orcanos design control system records the test plan and test results with the ability to report a None Conformity Report (NCR) during the testing state. In so doing, both manufacturers and customers will be able to track the performance of the device prior to the moment of manufacturing or service. Also, it will help identify any prior issues or faults. Finally, it helps to assure all parties that the device was in perfect working condition post-production or servicing.



In the medical device industry, it is possible that manufacturers in the process of servicing a system or device might ignore the role of complaints. While there is nothing wrong with servicing, it is crucial to leave room for complaints to ensure an effective CAPA. Hence, there should be a clear distinction between service systems and complaint systems. Orcanos eQMS comes with a built-in complaint management system that is separated from the service system. Orcanos CAPA management system allows integration natively with the complaint management system as well with the Risk system, all together empower the organization quality management capabilities.


For example, analyzing a diagnostic testing lab equipment. Picture a system that runs a buffer and requires the user to refill it using a buffer bottle. Now, suppose that the service engineer discovers leaks 62% of the time and fix it as part of their service call.


Then, it means that they would have successfully avoided a complaint system that would help track the issue with the product. As a result, there would be no feedback to the CAPA system or manufacturer that would alert them to the flaw in the product.


Major Issue

Such unclear roles in servicing can constitute a major problem in the long term. Therefore, it is important to avoid such issues by defining the roles of servicing and creating a way to have issues beyond servicing reported using the compliant system.

Also, all services and installation should be recorded and updated regularly.


Related Links:

Service Center: Complaint Management ORCANOS QMS – CAPA Management Software
 Customer Service – Orcanos



ISO 14971:2019 ( Medical Device Risk management ) | Detailed explanation Clause by Clause

June 9th, 2020 Posted by Requirements Management Tool 0 thoughts on “ISO 14971:2019 ( Medical Device Risk management ) | Detailed explanation Clause by Clause”

Application of Risk Management to Medical Devices Following ISO 14971:2019 Version

It is imperative to understand the Application of  Risk Management to Medical Devices. Technically, we could say it involves Identifying, Assessing, and Prioritizing risks. In general, it simply means that Risk Management helps us reduce risk.

Before the invention of ISO 14971, there were no standards for device manufacturers to use. Then came the idea of ISO 14971 where manufacturers could apply the principles contained in ISO 14971 list to their medical devices to ensure safety.

The product safety standard couldn’t address all the possible risks in medical devices, hence, the decision by the Standard Development Committee (SDC), to create ISO 14971, the first version of which was published in 2000. In 2007, another version was released.


The Evolution of the ISO 14971 Version

The European Union introduced a harmonized version that combined the two previous versions with new changes for European Device manufacturers. The Harmonized European Version harmonized the three directives related to medical devices namely;

  1. Active Implantable Medical Device Directive.
  2. Medical Devices Directive
  3. In-vitro Diagnostic Medical Device Directive.

As a result, any manufacturer that wants to sell their medical devices in Europe must comply with the EU 2012 harmonized standard. Meanwhile, the rest of the world can use the 2007 ISO 14971 and the 2009 ISO 14971 standards for medical device risk management.

The Importance of ISO 14971 2019 Version

There are a lot of changes that came with the 2007 ISO 14971 version. Similarly, the introduction of ISO 14971 2019 version came with several changes that differ from the 2007 version. Most of the changes between the 2007 and 2019 ISO versions are in the clauses.

The ISO 14971: 2007 had 9 clauses namely; 

  1. The Scope
  2. Terms and definition
  3. General Requirement for Risk Management
  4. Risk Analysis
  5. Risk Evaluation
  6. Risk Control
  7. Evaluation of Overall Residual Risk Acceptability
  8. Risk Management Report
  9. Production and Post Production Information. 

The Difference between ISO 149721: 2019 and ISO 14972: 2007

We’ll look at the changes adopted in the ISO 14971: 2019, but first we need to list the clauses. The current 2019 version unlike the 2007 version, has 10 clauses namely;

  1. Scope
  2. Normative Reference
  3. Terms and definition
  4. General Requirement for Risk Management
  5. Risk Analysis
  6. Risk Evaluation
  7. Risk Control
  8. Evaluation of Overall Residual Risk
  9. Risk Management Review
  10. Production and Post Production activities.

Note the introduction of a new clause (Normative Reference) to the latest edition in the second step. Also, there changes in the arrangement of the steps between steps 3 and 10. 

Likewise, some keywords changed in the latest version. For example, the Evaluation of Overall Residual Risk Acceptability was changed to the Evaluation of Overall Residual Risk. The Risk Management Report is now Risk Management Review. Lastly, Production and Post Production Information became Production and Post Production Activities. 

These changes might seem insignificant, but most companies have had to revise their documents to accommodate the changes.

There are other standards e.g IEC 62304, IEC 62366- 1, IEC 60601- 1, to mention but a few. The major difference between the ISO 14971 and other standards is their approach to risk management. ISO 14971 provides the fundamental procedures to manage all risks while other standards that attend to only specific risks. The combination of all these standards forms the basics of all medical devices’ risk management.

The Clauses of ISO 14971:2019

Clause 3: Terms and Definitions.

These terms include;

  • Hazard: This refers to the possible source of harm. Identification of all possible hazards is important for your product, be it chemical, mechanical, or any other form.
  • Harm: According to Section 3.3 of ISO 14971: 2019, harm refers to injury or damage to the health of people or damage to property or environment.
  • Hazardous situation: situations in which people, property, or environment are exposed to hazards of any form.
  • Benefit:  Good impact of the use of medical devices on the health of individuals, or a positive impact on patient management or public health.
  • State of Art: According to Section 3.28 of ISO 14971: 2019, it refers to the developed stage of technical capability at a given time as regards products, processes, and services, based on the relevant consolidated findings of science, technology, and experience.
  • Reasonably Foreseeable Misuse: Section 3.15 of ISO 14791: 2019 defines it as the use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behavior.
  • Risk: Risk is basically the probability of harm occurring, and the severity of that harm. It is the possibility, whether high or low of any of the aforementioned hazards causing harm to individuals. Once the hazard has been identified, it is then easy to go on with managing the risk.

Clause 4: General Requirement for Risk Management.

The sub-clauses include:

  • Risk Management Process – It involves the overall processes which producers establish, implement, and maintain throughout the lifespan of a medical device.
  • Management Responsibilities – Management responsibilities show the proof of the commitment of management to Management Risk Processes by the provision of adequate resources and qualified persons to carry out the job.
  • Risk Management Plan– It is a document that helps identify risk management activities and helps plan ahead throughout the production cycle. It is a dynamic document and can be updated at will.
  • Risk Management File – Location where manufacturers can find all records and documents relating to risk management. A manufacturer is required to establish and maintain a risk management file which contains evidence of  the following;
  1. Risk management plan intended
  2. Foreseeable misuse
  3. Risk analysis
  4. Risk evaluation
  5. Risk control and more.


Clause 5: Risk Analysis.

Risk Analysis is the use of available information to identify hazards and to estimate the risk – Section 3.19 ISO 14971: 2019. It involves the identification of hazards and hazardous situations, identification of characteristics that are related to safety, and risk estimation.

Clause 6: Risk Evaluation.

After risk estimation comes risk evaluation. It involves clearly identifying what amount of risk is acceptable. A common way of doing this is by the use of Risk Evaluation Matrix. As earlier stated, risk evaluation is basically what risks are acceptable and which ones are not, hence, the working principle of Risk Evaluation Matrix.

It is a chart of the occurrence of risk against the severity. The unacceptable parts are made red, the acceptable ones are marked green, and yellow stands for the middle region where further consideration is probably needed.

Clause 7: Risk Controls.

Section 7.0 of ISO 14971 provides that manufacturers shall determine risk controls that are appropriate for the reduction of risk to the acceptable level. Simply put, it refers to the steps you take once you’ve identified unacceptable risks. 

There are quite many options for Risk control, they include;

  • Inherently safe design and product
  • Protective measures in medical devices
  • Information for safety and training where appropriate.
  • Residual Evaluation Risk: Once risk control measures have been implemented, it is next to evaluate any residual risk using risk management plan criteria as a guide.
  • Risk-Benefit Analysis: In such cases where the evaluated residual risk is not deemed acceptable by the manufacturer, the intended medical use of the device is compared to the residual risk. If the intended use does not outweigh the residual risk, it means the risk is unacceptable. The manufacturer is expected to modify the medical device or its intended use. The device is however good to go if the intended medical benefits outweigh the residual risk.

Clause 8: Evaluation of Overall Residual Risk.

Having evaluated individual residual risks for your medical device, there is the need to also make an overall evaluation of the residual risk of your medical device. The occurrence versus severity chart is also used for this. If it happens that the overall residual risk of your medical device is not acceptable, that is, the overall residual risk is higher than the benefits, the medical device is not fit for sale.

Clause 9: Risk Management Review

This is a summary of all risk management activities stating any risk-benefit analysis and explanation of overall residual risk acceptability. It identifies voids between planned management activities and what was achieved. All identified voids should be filled before proceeding to sell your medical device.

Clause 10: Production and post-production information.

There are quite many ways of going about this, but the best method will be to use the post-market surveillance together with an upgraded risk management plan. Once the device is released, a post-market surveillance plan starts. It basically involves the monitoring of residual risks even when the device is out, to ensure the continued validity of the risk evaluation.


June 9th, 2020 Posted by Requirements Management Tool 0 thoughts on “Orcanos on FEMALE ENTERPRENEURSHIP IN MEDICAL AND HEALTHCARE Event”


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