This course provides an overview to quality management with regards to medical device product development, the requirements of the ISO 13485 standard including the processes and documentation needed.
Topics covered on the course include: the regulatory framework, the quality management system (QMS), documentation pitfalls, risk-based approach, management responsibility, product realization and traceability, complaints and CAPA.
We recommend this course for professionals who work with a quality management system in a medical device organisation where ISO 13485 requirements apply, and those who typically are engaged in supporting QA related tasks such as CAPA, complaints, risk management, documentation and internal auditing.
Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that has authored the latest versions of ISO 13485 and ISO 14971 standards.
He has vast ‘hands on’ experience, having developed, amongst other things, a mechanical chest compression device and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.
NOTE – The course program structure is subject to change