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:
Marcelo Trevino is an experienced senior director with Nihon Kohden America, one of the fastest growing manufacturers of patient monitoring equipment in the U.S. with a large global footprint. He directs the quality and regulatory affairs initiatives at corporate headquarters in Irvine, CA. The company’s product lines include enterprise patient monitoring as well as neurology and cardiology equipment. Prior to Nihon Kohden America, he led quality systems and regulatory compliance initiatives for several years as a senior manager at Medtronic’s Heart Valve Manufacturing Center of Excellence.
Marcelo has an extensive knowledge of medical device management systems (ISO 13485:2003) and international medical device regulations for the United States (FDA QSR), Australia (Therapeutic Goods, Medical Devices Regulations), Canada (SOR/98-282 and Canadian Medical Devices Conformity Assessment System), Japan (Pharmaceutical Affairs Law), and Europe (93/42/EEC Medical Device Directives). He holds a B.S. degree in industrial and systems engineering from ITESM in Mexico and an MBA in supply chain management from the W.P. Carey School of Business at Arizona State University. He is also a certified Quality Management Systems Lead Auditor by Exemplar Global and has consulted with several corporate executives in medical device firms to implement different process and quality improvement projects. Additionally, he is a Certified Six Sigma Black Belt and Biomedical Auditor through the American Society for Quality (ASQ) and holds certificates in environmental & sustainability management regulatory affairs management from the University of California, Irvine.
Marcelo has experience working on Lean Six Sigma projects and many quality/regulatory compliance initiatives the medical device industry in the U.S. and around the world. He has conducted third-party audits and has written several articles to assist corporations in their quest for quality and service excellence.