EU regulations require manufacturers of medical devices and systems prove the single-fault safety of their products. However, it is not clearly defined in detail how to comply with these requirements. This article explains which technical and legal requirements apply and which aspects should be considered during development.
There’s a greater emphasis on being able to demonstrate competence in performing required activities.
Product architects are challenged to address security throughout the device lifecycle.
With the publication of IEC 60601 3rd edition, manufacturers have been scrambling to meet EU and Canadian deadlines and formally incorporate a risk management process in the quality management systems. Device electrical and mechanical safety continues to be a critical path on the road to regulatory approvals and ongoing compliance.