ISO 13485:2016 in practice: building and running a medical device quality system

The standard clause by clause, what each requirement means in a real company, and how it connects to the EU MDR, the FDA QMSR and MDSAP.

This course is for quality teams who build or run a quality system: new quality managers, quality engineers, regulatory people, and start-up managers who are setting up a system from zero. It follows ISO 13485:2016 from clause 4 to clause 8, explains what each requirement asks for and how companies meet it, and shows in every module what the EU MDR, the FDA QMSR and MDSAP add. Each lesson is a few short slides, an explanation under each slide and a check question. The course explains the requirements in my own words, so keep your copy of the standard open beside it. It ends with a final test and a certificate of completion with a link anyone can use to verify it.

This course is for people who are new to quality and regulatory work in medical devices, for founders and managers who are building a quality system for the first time, and for engineers and team leads who need to know what the standard asks of their part of the company. It also suits experienced people who want to go through the whole standard in order, with its links to the EU MDR, the FDA QMSR and MDSAP.

Explain how ISO 13485 is built and how it relates to the EU MDR, the FDA QMSR and MDSAP. Set up the quality system and its documents, including the quality manual, the medical device file and document and record control. Describe what top management must do, including the management review. Plan product realization with risk management, and run design and development from planning to design transfer. Control suppliers, production, process validation, traceability and measuring equipment. Run feedback, complaint handling, internal audits, nonconformities and CAPA as one connected system. Prepare for certification, an MDSAP audit or an FDA inspection.