Learn the basic overview of the international medical device Quality Management System -- EU’s Quality Management System under ISO 13485:2016. Implementation, training requirements, content and annual internal audit / inspection expectations.
In the U. S., the Quality System (QS) Regulation (21 CFR Part 820) governs the manufacturing of medical devices, the device CGMPs. Outside the US, the majority of countries utilize ISO 13485, the international quality management systems standard for medical devices, together with EU’s MDR (Medical Device Regulation). What is the importance, and purpose, and the framework of ISO 13485’s basic requirements for design and manufacture of medical devices, as well as a summary of the key requirements, the 8 sections, terms, and the underlying purpose for the requirements? “Establishing, implementing and maintaining a company QMS under ISO 13485:2016 and a Notified-Body. Major discussion points: Regulatory requirements of the EU, that apply to the methods, facilities and controls used for device design and development, production, installation, documentation, and servicing. Also: the Quality Management System, Management Responsibility, Managing Resources, Planning, Design and Development / Control, Change Control, Purchasing, Production, and Monitoring, Analysis, and Improvement. Unique requirements of the EU device regulations.
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John E LincolnPrincipal, J E Lincoln and Associates
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years’ experience in U.S. FDA-regulated industries, 22 as a full-time consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.
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