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

In our August Newsletter you can read about medical device risk management as described in an example of ISO 14971 where the Probability of Harm is derived from two Probabilities (P1 - Probability of Hazardous situation occurring, and P2 - Probability of Harm occurring for the Hazardous situation). The article describes the benefits of decomposing Probability in two: P1 and P2, and provides you with automation tips for this approach when using the SoftComply Risk Manager app on Jira.

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 and training courses to learn more about medical device risk management or implementing a compliant quality management system on Atlassian stack.

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ISO 14971 (2019 version, Annex C) indicates that the probability of a Harm occurring can be decomposed in two probabilities, P1 and P2, where:

P1 = Probability of Hazardous situation occurring.

P2 = Probability of Harm occurring for a given Hazardous situation.

The overall probability of a Harm occurring becomes then P = P1 * P2

Advantages of Using this Approach

1. Separation of technical and clinical events

P1 is typically related to device failures or use errors. This is competence of the developers and engineer, who can give a good estimate (qualitative or quantitative) of a certain event occurring.

P2 is more related to the clinical aspects of the product. The probability of a patient or user being injured when exposed to a certain hazard can be better estimated by clinical specialists.

So, developers don’t have to “guess” the probability of a negative clinical impact and clinical specialists do not need to get involved in the technical aspects of the device.

2. Allocation of controls

Risk controls based on the design of the device have an effect on P1, i.e. they tend to reduce, or eliminate, the probability of certain failures occurring.

P2 is instead affected more by controls related to Protection and Information, i.e. mitigation by reducing or preventing the exposure of the patient / user to the hazardous situation.

A P1 * P2 approach is definitely favorable, in case technical and clinical events can be estimated separately with a good degree of accuracy. This is particularly valid for combination device or devices that channel drugs. In this case the physiological and clinical effect of hazards such as overdose or underdose are well known and can be assessed independently.

How to implement this approach with SoftComply Risk Manager & Jira Automation

Jira Automation is a no-code rule builder that enables customers to build if-this-then-that-rules based on events in Jira. It allows teams to automate their processes, save time, keep Jira up to date and focus on what’s most important.

Automation is perfect for minor automation tasks to achieve more from the existing features of any Jira app. In this particular case, we will use automation to update Probability (P) value when either P1 or P2 is updated.

To learn more about how you can use the approach of P1 and P2 with the SoftComply Risk Manager, please keep reading.

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NEW IN SOFTCOMPLY RISK MANAGER

Risk Manager logo no company name

The Server version of the SoftComply Risk Manager and the Risk Manager Plus now support search by Risk Class values. For example, if you'd like to find all risks with High Risk Class value, you can now find them with Jira issue query.

For additional tips & tricks on getting the most out of the Risk Manager, please see our how-to articles.

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NEW IN MDCG GUIDANCE DOCUMENTS

The European Commission's Medical Device Coordination Group has released an extensive template for the Clinical Evaluation Assessment Report, MDCG 2020-13, that companies can use as a part of their QMS.

This Clinical Evaluation Assessment Report (CEAR) template applies to MDR Annexes IX section 4 and Annex X section 3. It represents the minimum content for a CEAR and needs to be incorporated into the process and procedures of the notified body.

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First ever report on the state of Atlassian Ecosystem is about the power of apps, customisation, and 3rd party integrations. The report also explores the adoption of key digital transformation trends across the ecosystem — from automation to Agile, and DevOps. Read the report 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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