As QMS Rules Change, Device Industry Likely Faces Short-Term Pain—but Long-Term Gain

Posted February 12, 2019

A Timely Conference

The 2019 International Conference on Medical Device Standards and Regulations, organized by AAMI in coordination with BSI and the FDA, will take place April 24–25 in Reston, VA.

Global experts and regulators will provide updates on FDA initiatives, including the new Safety and Performance Pathway for 510(k) submissions; perspectives on the European Medical Device Regulation and the implications of Brexit; and an overview of the status of the Medical Device Single Audit Program.

For more information and to register, visit

The medical device industry is facing a “big quandary” in the face of changing regulations and requirements for quality management systems (QMS), a dynamic that will challenge the ability of companies to effectively stay atop of the shifting rules of the game and compete on the world stage.

“There is a lot of transition coming together at the same time, and that makes it difficult in terms of resources for both manufacturers and other key organizations,” said Marc-Henri Winter, a staff fellow in the Division of International Compliance Operations with the Center for Devices and Radiological Health at the Food and Drug Administration (FDA), during a roundtable conversation published in the January/February issue of BI&T.

In the United States, the FDA has signaled its interest in replacing its current Quality System Regulation, 21 CFR 820, with the requirements found in the international standard, ANSI/AAMI/ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes. Meanwhile, the three-year transition period for device makers to comply with the requirements set forth in that 2016 standard (away from the 2003 edition) is nearing its end in March. A new QMS requirement in Canada, related to the Medical Device Single Audit Program (MDSAP), kicked in at the start of this year. And in Europe, the transition period for the new Medical Device Regulation ends in May 2020.

“So much is happening, and I don’t think there are enough regulatory resources in Europe, let alone the rest of the world, to help companies,” said Edwin L. Bills, principal consultant of ELB Consulting in Overland Park, KS. “We’re in a big quandary right now.”

While all the experts agreed that this is a challenging time for the industry, several also said that the turmoil could eventually result in a simpler set of rules on the QMS front.

“As regulatory bodies look at converging to a single set of requirements, I think in the long run it will help with the globalization of medical devices, especially for smaller companies,” said Mike Ziemelis, senior engineering manager in the Integration Management office at Stryker in Kalamazoo, MI.

Mark Walker, owner of Walker Validation and Compliance, a consulting firm based in Knoxville, TN, agreed. A more universal understanding and application of a QMS, he said, can help any single company provide “more devices around the world.”

AAMI is hosting an international conference in April and provides training programs year-round to help medical device manufacturers navigate this changing terrain. One such course is The Quality System Regulation 21 CFR and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements, which is aligned with the FDA’s planned focus on 13485.