AAMI News October 2018

AAMI's New Quality System Course Aligns with Global Requirements, FDA Thinking

Pop quiz for medical device manufacturers: Is your quality management system (QMS) ready to meet new global expectations?

QMS expectations are evolving—and AAMI’s Quality System Requirements and Industry Practice course has been fully updated to align with new requirements and a new mindset from the Food and Drug Administration (FDA). It’s part of an ongoing broader revamp of the entire suite of quality system courses, with the goal of ensuring these courses are in sync with the latest FDA thinking and offered in an engaging format.

Here’s the backdrop: The FDA has indicated its intention to replace in April 2019 its current Quality System Regulation, 21 CFR 820, with an international standard, ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes. This
standard is designed to work with other management systems for the medical device sector “in a way that is efficient and transparent,” according to the International Organization for Standardization (ISO).

“This announcement will take global harmonization of regulatory requirements in the medical devices sector to the next level,” Wil Vargas, AAMI director of standards and secretary of ISO/TC 210, the technical committee that developed the standard, said in an ISO news release.

“This bold step by the FDA seems logical, considering the role of ISO 13485 as the foundation for the Medical Devices Single Audit Program (MDSAP), currently operated in Australia, Brazil, Canada, Japan, and the USA,” added Peter Linders, director of standards development and regulations at Philips Healthcare and committee chair, in the ISO news release.

Have Questions? AAMI Has Answers

To help medical device manufacturers broaden their knowledge of the changing regulatory landscape, AAMI has completely revamped the go-to course on QMS. This intensive, 4.5-day shared learning experience is the culmination of years of consensus development from respected quality system experts in industry, the FDA, and the committees responsible for developing ISO 13485 and ANSI/AAMI/ISO 14971, Medical devices—Application of risk management to medical devices.

“Updates have been made not only to the course content, but also to the methodology used to deliver the learning with increased learner engagement and simulations,” said Deidre George, AAMI director of industry training. “Attendees will be presented with exercises that walk them through the learning objectives and provided with templates and tools to apply to their products when they go home.”

Get Event UpdatesThe course is designed to answer your burning questions now:

  • Does your FDA-focused QMS meet ISO 13485 requirements?
  • What are the new expectations to meet the 2016 revision of ISO 13485?
  • Are you ready to host a successful MDSAP audit?
  • What do you need to make sure you are MDSAP-ready?
  • Do MDSAP audits require any changes to your quality system?

“We’ve changed the exercises so that they’re more engaging, so people can work with their peers through real problems that they would see,” said Jason Amaral, managing director of Emeraldwise, a Los Altos, CA, consulting firm, and an AAMI faculty member.

At the training sessions, “There is a lot of representation from companies, from industry, from regulatory agencies, and you have faculty members, so there are a lot of experience and viewpoints in the room that are at your disposal,” said Mario Wijker, vice president of global quality and regulatory affairs at Mölnlycke Health Care, headquartered in Gothenburg, Sweden. “The exercises really take the audience members into consideration—what they’re interested in, what problems they’re seeing, and what they would want to see discussed and resolved.

“The addition of the new ISO standard and the direct comparison with the Quality System Regulation is really interesting,” Wijker added, “and we’re seeing a lot more harmonization and alignment between those two elements. I think that addition or that change to the course is going to help a lot of companies become much more proficient in interpreting the requirements and the regulations and helping their companies move forward.”

The next sessions of this course are scheduled for Oct. 29–Nov. 2 in Arlington, VA; Dec. 3–7 in Manchester, UK; and Dec. 10–14 in Arlington, VA. Additional sessions are planned in 2019.