Orcanos issues new risk system including risk made by medical devices in the field of Neurosurgery Software Recalled Due to Display Inaccuracies

January 9th, 2019 Posted by ISO 14971, Recall, RISK Assessment, Risk Management, Safety 0 thoughts on “Orcanos issues new risk system including risk made by medical devices in the field of Neurosurgery Software Recalled Due to Display Inaccuracies”

Orcanos issues new risk system including risk made by medical devices in the field of Neurosurgery Software Recalled Due to Display Inaccuracies. The software, when used with the medical device Navigation System, provides 3D images of a patient’s brain to help neurosurgeons navigate surgical tools and implants used during surgery.

The Software glitch may affect the intended use of the device. This new risk, the following does not include reported problems that included a patient death potentially linked to the case.

It was a Class 1 recall alert for MRI-guided surgery device. Class 1 recalls, the highest severity level, involve product problems that can cause death or serious injury.

Hazard: The software displays incorrect information during biopsy procedures that could result in serious or life-threatening patient harm. During the procedure, the software monitor may show that the tip of the surgical tool has not reached the target and could prevent the neurosurgeon from accurately seeing the location of the tools in the patient’s brain.

Failure Cause: The offset appears to have been caused by an interaction between the device probe and the MRI environment

Failure Effect/ Harm: The surgeon could potentially insert the tool too deeply, damaging the patient’s healthy tissue, brain or blood vessels.

Risk Control (RISK-5005):


Orcanos 4.0 new release now includes a complete training program plan to support the GMP process

January 8th, 2019 Posted by e-GMP, Requirements Management Tool 0 thoughts on “Orcanos 4.0 new release now includes a complete training program plan to support the GMP process”

Orcanos 4.0 new release now includes a complete training program plan to support the GMP process. The Orcanos new release involves a set of optional training tasks with a list of topics and agenda to be covered in order to be in compliance with the GMP. These training topics are covering Medical Device and Pharma producers including Cannabis growers who need to comply with the enforcement of the strict regulations by the legislation of the local government.

Orcanos as a world leader in the eGRC and eQMS and ALM market happy to get you the list of topics in a specific each subject area according to your professional demands, please simply click www.orcanos.com to get your FREE edition.

Some covered subjects below:

  1. Quality Assurance
  2. Microbiology
  3. GMP in Pharmaceutical Development
  4. GDP
  5. Computer Validation
  6. GMP for APIs and Excipients
  7. Medical Devices
  8. Packaging
  9. GMP in Biotechnology
  10. Regulatory Affairs
  11. Quality Control
  12. Sterile / Aseptic Manufacturing
  13. Technical Operations
  14. Validation
  15. GMP Basic Training Courses
  16. Data Integrity

Here are some of the benefits of using Orcanos  as the foundation of your e-GMP system:

  • Automation and Standardization: With Orcanos eGMP software, you can standardize all documents-based processes and automate distribution/routing, review, follow-up, escalation, and approval of documents. It makes search and retrieval of documents faster and easier.
  • Centralized Platform: Orcanos can serve as a centralized platform for all quality documents and records critical to eGMP compliance, making it essentially your eGMP system. Orcanos is web-based so authorized users have access to the system from virtually anywhere 24/7 not holding your production line and allow granting confirmation service without the local presence or human resources.
  • Connectivity: Orcanos is unlike other eGMP software solutions in the sense that it can connect all quality processes, including document control, training control, audit management, nonconformance management, CAPA, MRB, DHR and change control. This connectivity will help ensure that quality and other issues will not fall through the cracks.
  • Mobile Access: With Orcanos adoptive technology, users can access the system using a tablet or a smartphone. This capability is a distinct advantage of Orcanos over other eGMP software solutions and it can be very helpful for users out in the field or those constantly traveling. Those users will be able to participate in documents-based processes critical to eGMP compliance even when they are not in their local office.
  • Validated System – Orcanos is a validated system that no customization requires any effort invalidation. It is fully CFR 21 Part compliance system and already servers many customers around the world.


Orcanos e-QMS 4.0 – The new MRB process, getting it all in one place, how it works!?

November 10th, 2018 Posted by Requirements Management Tool 0 thoughts on “Orcanos e-QMS 4.0 – The new MRB process, getting it all in one place, how it works!?”

The Orcanos e-QMS Material Review Board (MRB) software module within the Orcanos e-QMS and manufacturing software enables you to electronically document, manage and track discrepancies with materials, whether it is raw materials, work in process or finished goods. MRB (plural MRBs) (manufacturing) Initialism of Material Review Board, a system of recorded investigative checks done on failed components or processes to improve quality.

Together with the MRB, there is another process that needs to be discussed which is the RMA. RMA is Return Material Authorization; it means you are being authorized to return the material back to the supplier. The reason you need an RMA is when it reaches the receiving department of the supplier then they don’t know what to do with it. This gives you the paper trail you need to be able to do the credits. Orcanos e-QMS system allows you to define the RMA and to give you an electronic form to manage the process, at any point of time you can export this RMA form to other format and to send it out to your supplier together with Orcanos e-Signature system according to the CFR 21 Part 11 regulation requirements. While the MRB could be something which you get from your supplier which you think is of suspect quality. Isolate it so that you can review it, look at it and figure out what to do with that.

Here is an example that will illustrate the flow between processes and documentation. Customer reports a problem into Orcanos Service Call center and issues a complaint form (according to the ISO 13485 Sec. 8.2). The analysis of the complaint results in two decisions, one that there is a RISK (according to the ISO 14971) to be handled and second that there is a need for a CAPA. The RISK assessment that will result in additional actions that all are addressed by Orcnoas RISK management (RMF) system the other activity around the CAPA will result in 3 types of actions. The corrective action (CA) which may direct to some immediate action items such as training, supply chain etc. The preventive action (PA) may result in an MRB process which will create additional action all documented electronically inside Orcanos e-QMS system. The 3rd type of action shall be the effective action which will measure the effectiveness of the PA/CA actions on the forecast of such event to occur again.

Here is one   example how the MRB get into action:


Orcanos e-QMS, MRB example:

MRB Form

The new Orcanos e-QMS edition 4.0 now includes the MRB as part of the system templates and allows you to start working with it immediately.

Try Now for Free

Nobel prize technic on how make a decision about your management system

November 5th, 2018 Posted by Presentation, Tip Of The Week 0 thoughts on “Nobel prize technic on how make a decision about your management system”

Today I want to talk about the way we are making decisions. One way is to listen to your inside mystic voice telling you all kinds of fairy tells about do/don’t decision criteria, by the way, this can take you back to your mother voice in your head. Another way is to look at your decision in more statistical manner telling you what are the chances of making a GOOD decision and the 3rd technic is about our passive and active decisions that balance between the logical and emotional thinking.

On the most popular economical article of all times from 1979 by Prof. Daniel Kahneman who was our Nobel prize winner for economy describes a research indicating that we as humans feel that the bitterness of failure is 2 times larger than the sweetness of the success if we will take a decision. That means people are not taking actively decision, it is called “The Status Quo Effect”.

We meet everyday people that are in a situation where the emotional drive and the logical drive are in an equilibrium state. Yes, the forces of the day to day tasks do not let you stay there and you need to take a decision. Even if it is a decision to equip your organization with a software that can create for you controlled framework that you need in order to keep functioning under the daily tasks stress. The decision to stay passive and not do any change is much more attractive than the active decision to make a change.

How to take a decision in such matter, the way to do it is to separate from the active decision to positive decision. So in order to take a decision about system selection should start from the passive decision. Ask yourself what will happen if you do not take any decision, in that case, you will find the cost and pain that comes with not taking any decision, try to put numbers next to that cost. The default behavior of our decision process is not making a decision.

But if you want to make a change you need to do a bit more than do nothing. So now ask how you can take an active decision? Put yourself in the position of your next audit event. Now you do not know what will be the outcome of that audit, you do know what happened the year before and that you will be exposed to some faults. That though will drive you to take an active decision to make a change and have a system to reduce the chance for nonconformity. In other case imagine the time you spend every day on seeking and updating documents and the overhead activities you do to maintain the integrity of such documents. The idea is to change the passive decision to active by finding events close to your world and put yourself that point and evaluating your status quo of your organization.

Nobel prize technic

How to Evaluate Requirement Management Tool

October 17th, 2018 Posted by Requirements Management Tool 0 thoughts on “How to Evaluate Requirement Management Tool”

Author: Rami Azulay


The purpose of this article is to prepare the focus group doing evaluation for solution of Requirement Management System (RMS) and to provide the organization with the necessary information to effectively compare Requirements Management Systems solution among vendors to select the best RMS for their individual needs and cost parameters. Requirement management in software engineering is integral part of the daily work and needs to meet very specific needs by the stakeholders using it. We in Orcanos are proud to present the world our years of experience in RMS POCs and to share this with any prospect who seek to find the best solution for them. We believe in fair competition and not afraid to hear No Thank You from our prospects. There is no perfect solution but there is one that is perfect for you.


All information presented in this RFS, including any information that is subsequently disclosed by the Orcanos during the evaluation process, should be considered public and can be used by the public domain.


Orcanos (https://www.orcanos.com) is a software vendor since 2005, We hold blue chip customers as well small/medium companies which use our software for both ALM or/and QMS process.

Orcanos solution cover in a complete manner the requirements from RMS system and due to our presence in the regulatory industry our RMS system include some unique capabilities to address such special needs. Orcanos system is 21 CFR Part 11 compliance system and for that it can turn any organization to a paperless organization which can completely archive its data electronically. Some of the main important RMS capabilities may include Generation of document from the electronic system, prioritization of requirements, the replacement of Word and Excel documents or other systems. The objective of such SAAS system is to be able to bring all stakeholders into the same system, requirements are not easily analysed or traced from customer need through to technical specification and test plan. Changes to requirements are not well controlled or communicated. As the organization’s projects continue to grow with more complexity, the requirements documents grow correspondingly to larger scale, the number of project participants and stakeholders grows, and the need for rigorous handling of the development and maintenance of requirements becomes more critical.

Most organizations use a Stage-Gate project management process and makes use of techniques such as Quality Function Deployment (QFD), Failure Modes & Effects Analysis (FMEA), Design for Manufacture and Assembly (DFMA) and Design Validation Planning & Reporting (DVP&R) in its product development procedure. Orcanos RMS system is capable to capture all that in one single repository and by that create a transparent flow of information between R&D, Quality and Manufacturing. Other uses of legacy system such Microsoft Office Project Server for Project Portfolio Management (PPM), Atlassian JIRA for bug tracking and Agile development, and Applications for Enterprise Resource Planning (ERP) or any thing else, for that Orcanos system is using the Zapier 1000+ apps integration tool which give the freedom to collect information from satellite systems and bring them all back into the same repository.


1. Core Functionality






Requirement Rating
1.1 The RMS represents Requirements as first-class entities in the system, each with a free-form text description.
1.2 The RMS allows Requirements to be grouped into Products and Projects.
1.3 The RMS maintains a unique identifier for each Requirement.
1.4 The RMS can represent Requirements of different types, e.g. Customer Requirements, Business/Legal Requirements, Design Requirements, Validation Requirements, Production Process/Test Requirements, Project Requirements.
1.5 The RMS captures derivation relationships between Requirements, e.g. Design Requirements are derived from Customer Requirements and Business Requirements, similarly Validation Requirements and Production Test Requirements are derived from Design Requirements.
1.6 The RMS stores priority or ranking metadata for each Requirement.
1.7 The RMS can manage Requirements for multiple Products with closely related or overlapping Requirements, e.g. product variants with different performance ratings or feature combinations.
1.8 The RMS can store validation criteria or performance targets for each Requirement where relevant.
1.9 The RMS supports iterative product development, where the Requirements for a Project to develop iteration N+1 of a Product are based on the Requirements from iteration N, with additions, modifications, and deletions.
1.10 The RMS allows Requirements to be transferred between different iterations of a Project.
1.11 The RMS stores a short name or title and a detailed description for each Requirement.
1.12 The RMS supports free-form text and other content (not part of a specific Requirement) associated with a Product or Project, e.g. for frontmatter, high-level description, explanatory text, etc.
1.13 The RMS supports figures (diagrams/images) in Requirements and other content.
1.14 The RMS supports tables in Requirements and other content.
1.15 The RMS provides comment or discussion features linked to each Requirement.
1.16 The RMS supports management of standardised sets of Requirements that are reused across Products and Projects, e.g. for a product type, target country of sale, or production facility or process.
1.17 The RMS supports incorporation of sets of Requirements by reference, e.g. sub-components, or interface and protocol specifications.
1.18 The RMS supports rich text formatting (e.g. bulleted/numbered lists, bold/italics, special characters) in Requirements and other content.
1.19 The RMS can store files as attachments to Requirements.
1.20 The RMS can represent Requirements in a hierarchical structure, e.g. for sub-components of a Product.
1.21 The RMS can manage Requirements for non-NPD projects, e.g. business improvement projects.
1.22 The RMS can capture use cases for a Product alongside the Customer Requirements.
1.23 The RMS can distinguish categories of Requirement e.g. Electrical/Mechanical/Firmware, Functional/Non-Functional, etc.
1.24 The RMS supports rendering mathematical formulas (e.g. LaTeX) in Requirements and other content.
1.25 The RMS supports rendering vector drawings (e.g. block diagrams, flow charts, UML) in Requirements and other content.
1.26 The RMS can capture design concepts for a Product alongside the Design Requirements.
1.27 The RMS can capture metadata about the source of a Requirement, e.g. customer, legislative, internal standards.
1.28 The RMS can be customised to add new metadata fields to Requirements for specific needs.
1.29 The RMS can capture product design documentation e.g. design decisions or component choices, and their relationships to the Requirements.


  1. Process Control

Requirement Rating
2.1 The RMS captures the history of all changes to individual Requirements, including before/after, timestamp, and the responsible person.
2.2 The RMS captures the history of a Project, including a snapshot of all Requirements at a point in time, either continuously or at designated project milestones.
2.3 The RMS flags Requirements changes (either in content or being added to/removed from a Project) for review of impact to downstream Requirements.
2.4 The RMS captures timestamp, responsible person and a justification when adding/removing Requirements from a Project.
2.5 The RMS implements a Change Request process, where a change to the Requirements can be proposed and reviewed before being officially accepted into the project.
2.6 The RMS implements a digital sign-off process for approving Requirements at Project gates (milestones).
2.7 The RMS implements an acceptance process for Requirements that are not ultimately satisfied by the Project, allowing an unmet Requirement to be waived or deferred to a later Project.
2.8 The RMS digital sign-off process (2.6) supports requiring multiple approvers to sign off.
2.9 The RMS supports the QFD process for deriving Design Requirements from Customer and Business Requirements.
2.10 The RMS supports the (D/P)FMEA process for deriving Validation and Production Test Requirements from Design Requirements.
2.11 The RMS can track the implementation status of a Requirement, e.g. to show progress during a Project, or to show which Requirements are already satisfied by a previous Project.
2.12 The RMS supports management of the Validation process by capturing test outcomes and evidence associated with a Validation Requirement.
  1. Analysis

Requirement Rating
3.1 The RMS supports Traceability Analysis of a Project to assess the coverage (necessity and sufficiency) of the Design Requirements against the Customer and Business Requirements, similarly the Validation and Production Test Requirements against the Design Requirements.
3.2 The RMS supports storing or linking to an analysis of each Requirement, e.g. cost/benefit, technical risk, competitor analysis, conflicts with other Requirements.
3.3 The RMS supports storing or linking to an analysis of each Project, e.g. market trends, competitor offerings, project justification and ROI.


  1. Roadmapping

Requirement Rating
4.1 The RMS supports Roadmaps of future Products and Projects.
4.2 The RMS captures future Product requirements for consideration in the current Project, e.g. for provisional hardware or architectural decisions to allow for anticipated future development.
4.3 The RMS supports Roadmaps of technology and research required to deliver future product requirements.
4.4 The RMS can capture ideas and feedback for future projects, e.g. from Lessons Learned, warranty and manufacturability data, direct customer feedback, or usage data from connected products.
4.5 The RMS can track whether a given idea has received a formal response and if it was ultimately incorporated into a Roadmap or Project.
4.6 The RMS supports Roadmaps of external influences e.g. market trends, external technology development, or legislative changes.
4.7 The RMS implements graphical presentation of Roadmaps in a time-based format, e.g. Gantt charts.
  1. Integration

Requirement Rating
5.1 The RMS exports data to well-formatted PDF or Microsoft Word documents.
5.2 The RMS exports data to Microsoft Excel or CSV.
5.3 The RMS PDF or Word export function can be customised for content, reading order, and style.
5.4 The RMS PDF or Word export function can be filtered, e.g. by Requirement type, category, or other metadata.
5.5 The RMS exports data to Atlassian JIRA.
5.6 The RMS exports data to ReqIF format.
5.7 The RMS imports data from Microsoft Excel or CSV.
5.8 The RMS has an external API e.g. REST or SOAP.
5.9 If web-based, the RMS uses consistent, human-readable URLs for a given Requirement, Product and Project.
5.10 The RMS imports data from Atlassian JIRA.
5.11 The RMS imports/exports data to/from Microsoft Office Project Server.
5.12 The RMS has an Extension or Plugin API.
5.13 The RMS has a marketplace or ecosystem of third-party plugins.
5.14 The RMS exports data to IFS Engineering for product documentation.
5.15 The RMS imports data from IFS CRM for customer feedback.
  1. User Interface

Requirement Rating
6.1 The RMS supports multiple simultaneous users.
6.2 The RMS is designed with usability as a primary focus, e.g. it is easy for new users to learn and navigate, tolerant of user errors, and efficient (in time and the number of clicks/page views) to perform common operations.
6.3 The RMS supports a customisable framework (templates, checklists, or examples) for guiding users in authoring complete and correct specifications.
6.4 The RMS provides assistance (e.g. wizards, online help) for users on how to use the software effectively.
6.5 The RMS supports multiple users working on the same Project simultaneously.
6.6 The RMS supports sending email notifications for significant events, e.g. changes to Requirements that may impact a given user, Projects awaiting a user’s review or sign-off, etc.
6.7 The RMS supports mind mapping for Requirements and Roadmaps.


  1. Security

Requirement Rating
7.1 The RMS stores all Organization data within Australian legal jurisdiction.
7.2 The RMS supports backup and rollback of Organization data with at least daily granularity.
7.3 The RMS has the option to store all Organization data on Organization owned IT infrastructure (on-premise).
7.4 The RMS can use Microsoft Active Directory / LDAP for user authentication.
7.5 The RMS supports role-based access control to individual Products and Projects.
7.6 The RMS provides a complete security audit history for access to and modification of Organization data.
7.7 The RMS supports download/export of all Organization data into a non-proprietary format.
7.8 The RMS supports access via an SSL or VPN connection over the public Internet.
7.9 The RMS supports low-cost or free/unlicensed access to authenticated users for read-only usage.


Submissions should include information about the typical implementation and recurring fees, IT infrastructure requirements, and system administration overhead of the solution for a company size.


Submissions should be evaluated by the organization based on his review of the submission, response to follow-up questions, publicly available information about the solution, and customer references. This is to feel the organization ability to address future issues and to understand its level of professional team. Orcanos comes with 13 years hands on practice and has many success projects and lessons learns, we are here not only to do what you ask but also to tell what you should not do.


Please address all correspondence regarding such RFS to:

Rami Azulay

VP Marketing and Sales


Preventing Potential Recall by Testing Right Your Product

June 23rd, 2018 Posted by Recall, Risk Management, Safety, Tip Of The Week, Validation and Verification, Workshops 0 thoughts on “Preventing Potential Recall by Testing Right Your Product”

On the QA Geek Week giving the following lecture based on a selected example of recalls researched by Orcanos to provide some preventive actions methods on the validation and verification methodology. These recalls give an example of how to pay attention to simple observational engineering faults that could harm the patient. All are true stories that just happened during 2017 – 2018 years which were already reported the increase in recalls during Q1 2018. The numbers shows that it is to be the largest recall quarter since 2005. Orcanos R&D effort is to continue to be a market leader by daily investigating these events and integrating into actions in Orcanos ALM/QMS system, helping to prevent the next recall to our customers.

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10 Reasons Why To Use Electronic Quality Management System EQMS

June 2nd, 2018 Posted by Requirements Management Tool 0 thoughts on “10 Reasons Why To Use Electronic Quality Management System EQMS”

Medical Device Solutions

Ensuring Compliance, Improving Efficiency,
and Accelerating Time to Market




 Document Management



 Audit Management

Medical Device Solutions

Looking to Ensure Compliance, Improve Efficiency, and Accelerate Time to Market? The road from designing a new medical device to its actual delivery to recipients is long, bumpy, and expensive. Medical device manufacturers can lose millions of dollars in revenue for each day a new medical device is delayed from being delivered to market. If a new product is approved, the company manufacturing the device enters the next expensive phase: mass-production. To stay on top of this intense business and regulatory demands, medical device companies of all sizes throughout the world are turning to Orcanos to automate and streamline processes and enhance product development lifecycles, from concept to commercialization.

Solutions Specifically Designed for Medical Device Companies

Medical device companies have unique needs when trying to get their products to market faster while reducing overall costs and increasing internal efficiency. Orcanos produces software solutions that meet these needs by enabling medical device manufacturers around the world to enhance efficiency and implement effective processes. Our Solutions include:

Document Management

Thousands of documents generated throughout a company’s product lifecycle—such as those in the design history file (DHF) and device master record (DMR)—require a formal document management process to facilitate cross-functional collaboration and to ensure that documents are easy to track, retrieve, revise, approve, and share departmentally. Without an efficient system for managing documents, thousands of man-hours will be spent on even the simplest tasks. Orcanos’s document management solution provides a secure, web-based system for centralizing document collaboration and document control that improves efficiency, accelerates time to market, and ensures compliance.

Supplier Management

The complex process of accurately tracking suppliers on a company’s approved vendor list (AVL) requires continual management and monitoring. Such processes become exponentially more difficult as product designs and manufacturing processes change over time. Further complexities arise as increasing numbers of suppliers interface with different departments and divisions across the company. Orcanos offers companies the capability to efficiently manage and approve vendor lists and effectively track supplier quality and supplier status. Orcanos also automatically contains all supplier status and quality information (such as non-conforming material, COC, QC reports) in a single, easy to access location.

Risk Management

A consistent approach to assessing and managing risk is crucial to the successful quality and compliance management and precludes reputation damage from recalls or regulatory action. Orcanos integrates risk management throughout the organization to help unify all documentation and risk-related activities in a single centralized repository while providing a complete and accurate picture of the risk landscape across product lines and business processes.

Training Management

Tracking and documenting employee training is a regulatory requirement for the purpose of ensuring product quality. Orcanos automates the routing, tracking, documentation, training, and retraining of training tasks to help medical device companies meet rigorous regulatory requirements. Whenever there is a change in a Standard Operating Procedure (SOP) or other document linked to a course, all affected employees automatically receive new training tasks and notification via e-mail. Configurable training reports show pending, past due, and completed training, plus other critical information.

Quality Management

Quality event management is critical to success and profitability. By automating and effectively managing CAPA processes and integrating them with other quality endeavors, such as audits, nonconformances, customer complaints, and change control, Orcanos provides a foundation of excellence in controls, processes, and competency to guarantee that the solution implemented will provide the compliance results the organization demands and the methods and skills necessary for success.

Audit Management

Connecting audit processes with the entire quality system provide a holistic approach to quality management. Orcanos unifies and automates the scheduling of all audit-related activities to ensure that no vital processes are overlooked. With Orcanos, quality systems are consistently ready for inspections and audits.

Ten Reasons Why You Should Be Using Orcanos

  1. A fully integrated solution that connects all departments throughout the organization
  2. Reliable, consistent, and easy to use
  3. Orcanos’s unique transfer operational qualification (TOQ) provides completed validation and support documentation of IQ/OQ tests performed onsite at Orcanos, providing documented evidence that the applications perform correctly against their specifications
  4. Using an electronic, web-based system instead of paper-based systems saves time, resources, and money
  5. Flexible system – new modules, add-ons, and connectors can be added as needed
  6. Unparalleled expert technical support and customer service – support requests can be logged 24 hours a day
  7. Intensive training is available
  8. Compatible with most major integrators (i.e., Microsoft Office, Zapier, TFS, JIRA, GitHub etc.)
  9. Used by more than by giant and smb customers, including hundreds of medical device manufacturers throughout the world.
  10. Multiple languages and enterprise system architecture are designed specifically for multi-site, global deployments

Compliance Accelerated

Medical device manufacturers use Orcanos to meet key regulatory requirements while also increasing efficiency and keeping compliance costs down. Companies can enforce compliance
throughout every department and connect employees with relevant data and processes. The resulting environment enhances collaboration and allows managers to view all processes as a unified system. Call or visit www.orcanos.com to learn how hundreds of medical device companies are ensuring compliance and accelerating time to market.


Risk Management

April 30th, 2018 Posted by Risk Management 0 thoughts on “Risk Management”

In an ever growing world of products that continuously affect our safety, safety becomes a critical aspect that must be addressed in product delivery. This can be achieved using industry best practice, and tools that will assure safety and risk were addressed before shipping the product.

Most recalls show that too little is done too late for managing risk, and that is why it is a challenge. Risk analysis is a must — such as failure mode and effects analysis (FMEA) for medical devices, or automotive safety integrity level (ASIL)  in case your product integrates into the automotive industry. While risk analysis is important, it also complicates your product requirements. With FMEA, you need to prioritize risk and decide what to mitigate, eliminate, or accept. Complying with ASIL, you need to classify risk using ISO 26262.

Orcanos provides a fully integrated risk management system that allows you to easily manage your product risk and assure traceability for risk mitigation.

The Orcanos system enables the following:

  • Manage and track requirements of all types (hardware, software etc.)
  • Mitigate risk using FMEA analysis
  • Create a full traceability matrix for compliance
  • Support multiple types of mitigations, such as IFU, user manual, training etc.
  • Manage impact of change on product safety

Ready to manage risk?  Visit us at www.orcanos.com

ASPICE v3.0 best practice that supports the System Engineering Process Group (SYS)

April 8th, 2018 Posted by ASPICE 0 thoughts on “ASPICE v3.0 best practice that supports the System Engineering Process Group (SYS)”

Orcanos has released the ASPICE v3.0 best practice that supports the System Engineering Process Group (SYS).
The System Engineering Process Group (SYS) consists of processes addressing the elicitation and management of both customer requirements and internal requirements, the definition of the system architecture, and the integration and testing on a system level.


Orcanos ASPICE v3.0 supports the following processes and traceability:

SYS.1 Requirements Elicitation

SYS.2 System Requirements Analysis

SYS.3 System Architectural Design

SYS.4 System Integration and Integration Test

SYS.5 System Qualification Test


Orcanos’s innovative system acts as compliance engine that roles the entire process described by the ASPICE Process Reference Model. It creates new opportunities for all ISV suppliers who wish to penetrate the market of giants.


Our recent exposure to small players in the automotive domain, that cooperate with giants such as  BMW, VW, and Mercedes-Benz, presented the complexity those vendors are facing in order to comply with the ASPICE requirements.


Experience our ASPICE compliance engine yourself, and register for a free demo at https://goo.gl/aA3TW2


Follow Orcanos Software for more news and releases coming up this month regarding the ASPICE compliance engine on LinkedIn, Twitter and Facebook

System Engineering Process Group

The third-leading cause of death in US most doctors don’t want you to know about

March 1st, 2018 Posted by ISO 14971, Risk Management, Safety 0 thoughts on “The third-leading cause of death in US most doctors don’t want you to know about”

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