Medical Device and Pharmaceutical Product Development and Compliance

Medical device manufacturers face significant pressures to bring safer products to market faster. However, meeting critical project milestones and launch dates on time and within budget is becoming increasingly difficult. Medical devices are becoming more complex—which makes product development more difficult. At the same time, industry standards and regulations are evolving, placing new pressures on quality, regulatory, and engineering teams.

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.