The ISO 13485:2016 Foundation Training is a programme that covers the requirements of the quality management system standard specifically designed for the medical device industry, its key differences from ISO 9001, and its relationship with regulatory legislation. The training addresses design and development controls, risk management (ISO 14971) integration, supplier evaluation, and validation processes. Participants gain an understanding of EU MDR/IVDR and FDA 21 CFR Part 820 requirements, and learn about technical file preparation and the notified body process. The training is suitable for employees of medical device manufacturers or suppliers, quality assurance teams, and regulatory compliance officers.
ISO 13485:2016 is a quality management system standard designed for medical device manufacturers and suppliers. This training covers the structure, core requirements, and relationship of the standard with medical device regulations (EU MDR/IVDR, FDA).
1 day (8 hours)
