Global medical device manufacturers must undergo audits of their quality management systems by regulators in the countries in which they sell their products. This could mean multiple audits by numerous agencies each with their own scientific principles, requirements and processes.
Medical Device Single Audit Program (MDSAP) was introducted by the International Medical Device Regulators Forum (IMDRF) to develop a single audit of a quality management system that satisfies medical device regulatory authorities. The impact is recognized Auditing Organizations (AOs) conduct a single audit of a medical device manufacturer that will meet the requirements of multiple regulatory agencies. The program is expected to be fully implemented in 2017.
Download this 7-page whitepaper to learn:
- What is MDSAP?
- What are the driving factors and impact on the Medical Device Industry?
- Why prepare now?