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IEC62304 Compliant

Following up on our first blog post on how to become a trusted software supplier to established medical device manufacturers with the help of IEC 62304, we will now shed some light on specific clauses and requirements from that standard.

IEC 62304:2006/Amd 1:2015, 4.3 - Software Safety Classification

The 2015 amendment of IEC 62304 provides more clarity on the classification of medical device software, so make sure you are using the latest version of the standard.
The software can be class A, B or C, in order of risk. The risk is based on the potential effects of a software failure, without considering any mitigation internal to the software itself.

...continue reading...

IEC 62304:2006/Amd 1:2015, 5.1.1 - Software Development Planning

As per all regulations and best practices of the Medical Device industry, a plan must predate any action.
The Software Development Plan is one of them. It can be part of a system-wide plan, but you have to ensure it contains the minimum requirements of this clause of IEC 62304. Or it can be broken into several smaller plans.

Continue reading about the specific requirements of IEC 62304 for planning, processes and traceability in our latest blog post.

Risk Manager logo no company name

For tracking changes in risk management over time you might want to have versioning of your risk management table and risk reports.

In other words, you may want to take a snapshot of the current status of your risks for an audit, archive that status and continue managing these risks in real time. Below is a detailed description about how you could do that with SoftComply Risk Manager add-on for Jira.

For instructions on how to manage versions in SoftComply Risk Manager, please read on from guidance to manual risk versioning.


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Benefits of the SoftComply Risk Manager:

▪ Fully customizable for any type of risk project
▪ Automated traceability
▪ Supports FDA approval and CE-marking process
▪ Most competitive price
Fully customizable for any type of risk project
Automated traceability
Supports FDA approval and CE-marking process
Most competitive price

Benefits of the SoftComply eQMS:

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

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.

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