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.
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Procedures for design validation must address risk analysis where appropriate.
Medtech companies should be taking a broad approach to assessing risk.
Risk Management is the single most important topic impacting the medical device industry today.