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We hope you and your loved ones are safe during these challenging times!

Our June Newsletter brings you the news about our online webinar series that cover the topics of medical device risk management in Jira; establishing traceability between risks, requirements and test cases; medical device regulations & implementing a compliant QMS in Confluence; medical device cybersecurity and data protection regulations and more. This newsletter also describes what should be included in an ISO 14971 compliant Risk Management File.

In light of the global Covid-19 crisis & the importance of medical innovations in today's world, we have considerably lowered the prices of the SoftComply Risk Manager on Jira Cloud!!!

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Join our webinars to learn more about any of the following topics:

1. Intro to Medical Device Cybersecurity - EU morning time (to register)
2. Intro to Medical Device Cybersecurity - US morning time (to register)
3. Medical Device Regulations & how to implement a compliant QMS in Confluence (to register)
4. Medical Device Risk Management in Jira (to register)
5. How to establish risk traceability in Jira & Confluence (to register)
6. Medical Device Cybersecurity & Data Protection Regulations (to register)
1. Intro to Medical Device Cybersecurity - EU morning time (to register)
2. Intro to Medical Device Cybersecurity - US morning time (to register)
3. Medical Device Regulations & how to implement a compliant QMS in Confluence (to register)
4. Medical Device Risk Management in Jira (to register)
5. How to establish risk traceability in Jira & Confluence (to register)
6. Medical Device Cybersecurity & Data Protection Regulations (to register)
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What is a Risk Management File?

ISO 14971:2019 defines the Risk Management file as a “set of records and other documents that are produced by risk management”.

In practice, the risk management file must contain, or have reference to, the following documents:

1. (4.2, Note 3) The policy for establishing criteria for risk acceptability.
2. (4.4) The Risk Management Plan.
3. (4.5) Traceability for each identified hazard to the risk analysis, the risk evaluation, the implementation and verification of the risk control measures and the results of the evaluation of the residual risks.
4. (5.1) The Risk analysis.
5. (5.2) Intended Use and Reasonably Foreseeable Misuse.
6. (5.3) Qualitative and quantitative characteristics that could affect the safety of the medical device. Where appropriate, the manufacturer shall define limits of those characteristics.
7. (5.4) Hazards, the reasonably foreseeable sequences or combinations of events that can result in a Hazardous Situation, and the resulting hazardous situation(s).
8. (5.5) Risk Estimation.
9. (5.5) The system used for qualitative or quantitative categorization of probability of occurrence of harm and severity of harm.
10. (6) Risk Evaluation.
11. (7.1) Risk Control Measures.
12. (7.2) Verification of Implementation of the Risk Control Measures.
13. (7.3) Evaluation of Residual Risk.
14. (7.4) the results of the Benefit-Risk Analysis.
15. (7.5) Risks arising from implemented risk control measures.
16. (7.6) Review of completeness of risk controls.
17. (8) Evaluation of Overall Residual Risk.
18. (9) Risk Management Report, including Risk Management Review.
19. (10.3) Results of the review of the post-production information.
20. (10.4) Decision arising from the review of post-production information.
1. (4.2, Note 3) The policy for establishing criteria for risk acceptability.
2. (4.4) The Risk Management Plan.
3. (4.5) Traceability for each identified hazard to the risk analysis, the risk evaluation, the implementation and verification of the risk control measures and the results of the evaluation of the residual risks.
4. (5.1) The Risk analysis.
5. (5.2) Intended Use and Reasonably Foreseeable Misuse.
6. (5.3) Qualitative and quantitative characteristics that could affect the safety of the medical device. Where appropriate, the manufacturer shall define limits of those characteristics.
7. (5.4) Hazards, the reasonably foreseeable sequences or combinations of events that can result in a Hazardous Situation, and the resulting hazardous situation(s).
8. (5.5) Risk Estimation.
9. (5.5) The system used for qualitative or quantitative categorization of probability of occurrence of harm and severity of harm.
10. (6) Risk Evaluation.
11. (7.1) Risk Control Measures.
12. (7.2) Verification of Implementation of the Risk Control Measures.
13. (7.3) Evaluation of Residual Risk.
14. (7.4) the results of the Benefit-Risk Analysis.
15. (7.5) Risks arising from implemented risk control measures.
16. (7.6) Review of completeness of risk controls.
17. (8) Evaluation of Overall Residual Risk.
18. (9) Risk Management Report, including Risk Management Review.
19. (10.3) Results of the review of the post-production information.
20. (10.4) Decision arising from the review of post-production information.

This seems a lot, but let’s look into the details of these items...

To keep reading, please continue here.

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Check out the short video clips on how to manage risks with SoftComply Risk Manager in our YouTube channel

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Benefits of the SoftComply Risk Manager PLUS for Jira Server:

▪ Supports Hazard Analysis and FMEA
▪ Supports FMEA with Detectability
▪ Displays risks in Matrices & RPN
▪ Supports FDA approval and CE-marking process
▪ Targeted towards safety critical domain users
Supports Hazard Analysis and FMEA
Supports FMEA with Detectability
Displays risks in Matrices & RPN
Supports FDA approval and CE-marking process
Targeted towards safety critical domain users

For full list of features of SoftComply Risk Manager PLUS, please check out the User Guide. Try it out for free for a month and/or contact us to get a demo & discussion about the features.

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Benefits of the SoftComply eQMS:

▪ Full Quality Management System for medical device co-s
▪ On ISO13485, IEC62304, ISO14971, FDA 21CFR 820
▪ Fully customizable with embedded guidance
▪ Reduces the cost of compliance
▪ Most competitive price
Full Quality Management System for medical device co-s
On ISO13485, IEC62304, ISO14971, FDA 21CFR 820
Fully customizable with embedded guidance
Reduces the cost of compliance
Most competitive price

SoftComply eQMS on Confluence Cloud:

The new MDR states that Quality System documents need to be searchable. You can now implement a compliant Quality System documentation on your Confluence Cloud! Access the free trial version directly from the Atlassian Marketplace and/or contact us to get a demo & discussion about the content of the product.

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Benefits of the SoftComply Risk Manager:

▪ Supports any software system/product risk management
▪ For both Jira Server & Cloud users
▪ Fully customizable for any type of risk project
▪ Automated traceability
▪ Support software system/product risk management
▪ Most competitive price
Supports any software system/product risk management
For both Jira Server & Cloud users
Fully customizable for any type of risk project
Automated traceability
Support software system/product risk management
Most competitive price

For full list of features of SoftComply Risk Manager, please check out the User Guide. Try it out for free for a month and/or contact us to get a demo & discussion about the features.

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