RQM+ Live! is an interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device and diagnostics industries. The panelists also answer your questions live! Every episode is added to our podcast, too.

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RQM+_Live_54_Recorded

FDA requires companies to conform to the current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR 820). However, many other international regulatory authorities require compliance to the internationally recognized regulatory requirements of ISO 13485.

This misalignment has created extra challenges for companies who market devices in multiple countries, as they have to meet two different sets of requirements. After many years of effort, including participation in the Medical Device Single Audit Program (MDSAP), FDA has released a proposed rule to amend the CGMP requirements of the QS Regulation to align more closely with ISO 13485:2016. While 21 CFR 820 and ISO 13485:2016 share many requirements, there are various differences regarding risk management principles, quality system record requirements (i.e. Device Master Record, Design History File, Device History Record), labeling and packaging controls and others. While this creates the opportunity to have one quality system to address all country requirements, companies need to update their quality system to ensure it complies with the new requirements.

In this show, subject matter experts including former FDA CDRH representatives provide insight on the changes in the new requirements and what steps companies should be taking to update their quality system.

  • Ralph Asencio, MBA, BSME  Vice President of Technical Services
  • Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services
  • Richard Freeman, Ph.D. – Director, Global Audit Practice
  • Kevin Go – Project Engineer, RAC (former FDA CDRH Lead Reviewer)

"With partners like you I feel even more confident. I’m very appreciative of how you are presenting both short and long term solutions and speaking your ‘regulatory philosophy’ out loud."

Director, Clinical Compliance, Multinational Medical Device Manufacturer