Medical Device and Pharmaceutical Product Development and Compliance

Risk analysis is crucial for ensuring safety and efficacy, but a recent survey of 100 medical device development and quality leaders revealed that many lack confidence in their current risk analysis processes.

SEPARATE RISK MANAGEMENT AND FMEA FOR BETTER MEDICAL DEVICE DEVELOPMENT. The below is an excerpt of the article originally published on MDDI. FMEA (Failure Mode and Effects Analysis) is utilized to identify potential failure modes in the design or manufacturing of a product. But risks associated with medical devices are not created by failures alone. A product may never fail, but there are still potentially many other risks.