Medical Device Quality Management: ISO 13485

Medical devices are judged on safety as much as performance, and regulators worldwide use ISO 13485 as the backbone of device quality. This Specialist course takes you through the standard as it works inside a real company: defining scope for your role, controlling documents and the medical device file, leading management review, applying ISO 14971 risk management and design controls, controlling suppliers, validating production, sterilisation and packaging processes, and handling complaints, nonconforming product and CAPA. Real recalls and workplace cases show what goes wrong and how auditors spot it, and you see how the standard links to EU MDR, the FDA Quality Management System Regulation and MDSAP. You finish with a practical toolkit of eight templates you can adapt for your own system.

ISO 13485 is required or expected by device regulators in the EU, the US, Canada, Australia, Japan, Brazil and the Gulf, so QA and RA staff who can run and defend a device quality system are needed by manufacturers, contract manufacturers, sterilisers, importers and distributors. The course suits quality professionals moving into medical devices and those preparing their organisation for certification or inspection.