Description
2022 Michigan Medical Device Summit - Breakout 6
Proposed Changes to 21 CFR 820 Quality Management System Regulation - Practical Considerations
Session Description
The FDA is proposing to amend the current good manufacturing practice (cGMP) requirements of 21 CFR Part 820 Quality System Regulation (QSR) to align more closely with the requirements of the internationally recognized ISO 13485:2016 “Medical Devices - Quality Management Systems – Requirements for Regulatory Purpose”.
The FDA wishes to align its current regulatory framework “to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.” What does all this mean for the medical device manufacturer?
Speakers
Mark Durivage, Quality Systems Compliance, Managing Principal Consultant and Member
Summit Description
Advancing Healthcare and Improving Lives Through Medical Technology
The Michigan Medical Device Summit is the annual gathering of the statewide medtech community. It is designed for attendees to learn about the latest in medical device technologies, regulations and marketplace, and especially what Michigan’s cluster has to offer to those developing and manufacturing innovative medical products. Hear the state’s most outstanding medtech and related thought leaders share their perspectives on topics of the day.
Meet and network with medtech sector professionals, academic researchers, healthcare providers and clinicians, suppliers and contract manufacturers, professional services firms, investors, business leaders and government officials, and disruptive companies across all growth stages.
The Summit is intended to better connect and raise the visibility of Michigan’s large medtech cluster including its significant innovation and supply chain assets that are contributing to its steady growth and economic impact. New in 2022 is a showcase of Michigan firms supplying and serving the medtech community.
