Medical software risk management

Remember, the risk classes below are independent of the overall risk classification of your device according to US FDA or EU regulations. Here are the three IEC categories defined in:. These are of course simple terms, as the categorization also needs to include considerations of risk control and risk acceptability. You are required to address all activities within IEC , but tailor the rigor and amount of documentation proportional to the risk associated with your software.

It would be difficult to generate additional documentation for software if your classification is not accepted by a regulatory reviewer. Going from Class A to B may not affect the risk of your software, so think carefully about your classification and document the logic behind your decision. Download a full-linked copy of the MDR here. Here are the sections you will want to review:. Annex I, Chapter 1, Sections — Deals with the general requirements, including application of risk management.

Although ISO is not mentioned in the EU MDR, the clauses provide a direct link to risk management principles so it is important that you review them. Challenges with software often include understanding user impacts, and unforeseen events that can occur with software or software-controlled devices.

Annex 1, Chapter 1, Section 17 — Meeting the requirements of this section necessitate the following:. Annex 1, Chapter 1, Section 22 — Talks about how software must be designed for lay users and their environment. Guidance documents issued by FDA reflect their current thinking on a topic. Here are some of the major regulatory obligations you should know:. As embedded software and SaMD play an increasingly important role, it is critical that developer and regulatory professionals understand their regulatory obligations.

Our risk management consulting services and training classes as well as our Medical Device Software Development, Verification, and Validation Training or Medical Device Cybersecurity class will arm you with the foundational knowledge you need to develop medical device software or SaMD in compliance with US, European, and international risk management requirements. Need Assistance? Verification and Validation. Design Verification and Validation Seamlessly manage traceability to test cases used for verification and validation.

Key Benefits. Align to regulatory requirements quickly. Reduce barriers to medical device compliance. Simplify audit preparation and data exports. Get your product to market faster. Key Features. Standard frameworks aligned to key industry regulations. Learn More.