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MDR: UP-CLASSIFICATION & EXTENSION PERIOD
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For a number of Medical Device companies, Christmas arrived earlier in 2019.

On the 17th December 2019, the second Corrigendum to the Medical Device Regulations was formally approved.

This has interesting consequences for some Class I devices, that until now would have had to go through the full rigour of the MDR as of the 26th May 2020.

Class I devices that have a valid Declaration of Conformity or Certificate can be placed on the market until the 26th May 2024, without the need of being up-classified immediately.

...to continue reading...
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FDA 21 CFR 11 COMPLIANT QMS SOLUTION ON CONFLUENCE
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SoftComply together with Comalatech and Clearvision are happy to present the very first FDA 21 CFR 11 compliant electronic Quality Management System on Confluence!

This Confluence based solution includes a full QMS documentation, digital document control with document approval workflows and e-signatures as well as compliant access management. The solution is pre-configured, maintained and hosted on AWS according to your company needs.

To learn more about this solution, please visit MediCompli product page, read a short blog post about the solution or take a look at the MediCompli video where we introduce the features of the solution.

In case of interest or to arrange a call to learn more about it, please contact us.
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NEW FEATURE OF SOFTCOMPLY RISK MANAGER ON CLOUD

SoftComply Risk Manager on Jira Cloud now supports user created "link type" columns in the Risk Table.

This feature enables users to map various existing Jira issue link types to the risk management table. In addition to our existing Mitigation links and Verification links columns you can now create similar columns yourself for, e.g. "Blocks" or "Relates" or any other link types.

How can I benefit from it?
Now risk managers can set up more complex traceability by, for example, creating separate risk projects for hardware and software risks, and connecting those risks with the new link columns feature in the overall risk management table.

Feel free to add the new link type columns in system administration view for creating custom links between risks and other existing Jira issues as needed.
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ATLASSIAN SUMMIT 2020 - March 31 to April 2

Join us at the Summit in Las Vegas for great talks, latest product news and wonderful networking possibilities.

As Summit Sponsors, we are able to offer you a 25% discount of your Summit pass!

Contact us at SoftComply to get the discount code.
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Interesting Reading on MedTech, Regulatory Compliance & Atlassian
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1. US FDA recognizes the latest edition of ISO 14971:2019 as a consensus standard
2. MedTech Trends in 2020
3. Dr. Google & its claim of Health Data
4. What will the MedTech sector in EU look like under the MDR
5. The latest news on Atlassian ecosystem & Marketplace apps
1. US FDA recognizes the latest edition of ISO 14971:2019 as a consensus standard
2. MedTech Trends in 2020
3. Dr. Google & its claim of Health Data
4. What will the MedTech sector in EU look like under the MDR
5. The latest news on Atlassian ecosystem & Marketplace apps
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Recent posts on SoftComply Risk Manager & SoftComply eQMS that you may want to check out:

On Safety-Critical Risk Management on Jira:
* How to set notifications for your risks in Jira
* New Features of SoftComply Risk Manager and Risk Manager Plus
* Validation Packages for SoftComply Risk Manager and Risk Manager Plus
* Managing Safety-Critical Product Risks in Jira
* How to mitigate Medical Device Risks in Jira
* Hazard Analysis & FME(C)A on Jira
* What is FMEA?

On Quality Management on Confluence:
* How SoftComply eQMS helped speed up the CE-marking - Case Study
* Don't be a "victim" of your Quality System!
* SoftComply eQMS for Medical Device companies on Confluence
* How to set page level restrictions in Confluence

On Regulatory Compliance of Medical Devices:
* On FDA, Compliance and Cloud tools
* Overview of Medical Device Software Regulations and Standards
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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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eQMS logo no company name

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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Risk Manager logo no company name

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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