Improving Quality Processes For Medical Device Development And Manufacturing

By Mike Kuehne, ACSYS, Inc.

Organizations that consistently develop and launch new products efficiently in an environment of increasing regulatory scrutiny, successfully manage regulatory risk. Organizational regulatory risk management capabilities may become a competitive advantage for all development stages. This report will address the regulatory risk of medical device development and manufacturing through a review of regulatory trends over the period Q1’11 to Q2’12. The information presented is focused on medical device development and production. A thorough review of all FDA activity in the area of medical device development and production provides insight into regulatory risks. This information is used to:

• Evaluate and review suppliers (internal and external).
• Develop effective strategies for managing medical device development initiatives.
• Establish improved monitoring programs for manufacturing performance.
• Ensure proper documentation review (design control, materials/components, complaints).
• Identify risks associated with manufacturing, distribution and reporting of medical devices.

Regulatory trends highlight areas of concern for medical device manufacturers and provide valuable information to prioritize initiatives, implement training and develop metrics to proactively monitor critical business functions.