In the highly regulated medical device world, standards and regulations are continuously evolving to ensure that the highest levels of quality and safety are achieved. To that end, international regulators have long recognized the value of developing a standardized, global approach to auditing and monitoring medical device manufacturing, and for the last five years, the International Medical Device Regulators Forum (IMDRF) has spearheaded an effort to create such a framework.
Since 2014, IMDRF has been conducting a pilot of the Medical Device Single Audit Program (MDSAP) with participation from Australia, Canada, the U.S, and Japan. The pilot will conclude by the end of this year, with the expectation that the “official” MDSAP will be fully operational in 2017. In fact, MDSAP will replace the current Canadian Medical Device Conformity Assessment (CMDCAS) program, even in situations when a manufacturer intends to sell only in Canada. As of January 1, 2019 Health Canada will only accept certificates issued under MDSAP.
MDSAP implementation is looming, and the program will likely become the new model to follow for most medical device manufacturers selling internationally. There are significant benefits to having one audit per year on a predictable schedule, lowering costs from auditors and regulatory agencies, improving resource allocation, and creating an opportunity to make the quality system more robust and efficient.
Through this 90 minute course you will learn to benchmark your existing quality system process against the MDSAP and understand the changes that will need to be implemented in your organization to participate. The course will also cover the details and guidance documents associated with the program and will highlight expectations from regulators and notified bodies.
Discussion topics include:
- Reviewing the most significant changes affecting medical device standards and guidance documents
- Understanding the MDSAP (goals and strategy)
- Analyzing the MDSAP main differences with standard auditing
- Understanding grading of MDSAP non-conformances
- Assessing MDSAP Audit structure and reporting to regulators