Christopher Joseph Devine
Dr. Christopher J. Devine is the founder and president of Devine Guidance International Inc. (DGII), a medtech establishment that provides consulting services to the medical device and pharma industries. Dr. Devine has over 45 years of combined experience in the fields of quality assurance, regulatory affairs, and design and development of medical devices. He is a senior member of the American Society of Quality (ASQ), a member of the Regulatory Affairs Professionals Society (RAPS), a member of the Society of Manufacturing Engineers (SME), and a member of the Project Management Institute (PMI). Dr. Devine received his doctorate from Northcentral University, with his doctoral dissertation entitled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study.” Prior to launching his commercial career, Dr. Devine served honorably in the United States Marine Corps. During his downtime, Dr. Devine is active in his community, volunteering as a deputy sheriff supporting the Search and Rescue Division of the Lyon County Sheriff’s Office.
Friday September 19, 2025
FDA's New QMSR Is on the Horizon—Will Your Company Be Ready?
On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world.” Considering 21 CFR 820 has been the agency’s standard for multiple decades, what is the impact of this alignment with ISO 13485:2016 and how will FDA implement and enforce compliance? The drop-dead date for compliance has been slated for February 2, 2026; and medtech companies (globally) will be expected to comply with the changes. This presentation will dive into: (a) the nuances of the FDA’s changes; (b) edits made to 21 CFR, Part 4 (clarification for combination products); (c) FDA’s development of a new inspection process that better aligns with ISO 13485 requirements; (d) requirements/expectations for compliance; and (e) future changes made to ISO 13485.