The revised MDD 93/42/EEC came into effect on March 21, 2010 and the changes will impact all medical device manufacturers that CE mark their products or plan to do so in future.
18 months later, questions remain about the updated regulation. One of the big questions is: How should software be designed to ensure the repeatability, reliability and performance of systems according to the intended use?
Complying with EU Requirements for Medical Device Software addresses how, in the event of a single fault condition in the system, appropriate means can be adopted and documented to show that risk has been eliminated or reduced as far as possible. Poul Schmidt-Andersen is an expert in the field, and in his presentation he covers how to establish suitable documentation to demonstrate compliance and satisfy Notified Body reviewers.
If you or your group is involved with medical device software development, you don't want to miss Complying with EU Requirements for Medical Device Software.
For more on the intersection of software and regulation, take a look at:
- When is software a medical device?
- What's the fuss about IEC 62304?
- Introduction to software localization
- Software localization requirements in Japan
ForeignExchange's QMS is certified to ISO 9001, ISO 13485, EN 15038 and compliant with ISO 14971. For your next medical translation and software localization assignment, request a detailed proposal from ForeignExchange.