ISO 13485 Certification Support • 12 Expert Days

Who it is for : Medical device manufacturers and their suppliers, with the quality and regulatory teams responsible for an ISO 13485 QMS that has to satisfy EU MDR and a notified body.

The 12-day programme, over up to 12 months : *Fundamentals (0.5 day): ISO 13485 principles, risk-based thinking and the PDCA cycle *Vision and strategy (1.5 days): align the QMS with your device portfolio and regulatory strategy, map issues and risks *Process approach (4 days): map your processes, including design controls, production and supplier management, with performance indicators *Information management (1 day): structure your technical documentation and records, retire what is redundant *Continuous improvement and compliance (4 days): non-conformity and CAPA management, device-specific requirements, management review preparation *Mock audit (1 day): a full dry run led by an external consultant, with corrective actions closed before the notified body audit

What you get : Each session leaves you with usable tools, a written report and an action plan, and the in-house capability to keep the QMS compliant between audits.

Standards : ISO 13485, aligned with EU MDR.