Course overview
Sets out the requirements for a quality management system (QMS) for medical devices. It helps organizations demonstrate their ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
The Foundation pathway helps learners build knowledge and practical understanding relevant to ISO 13485. Course availability, official learning objectives, examination and certificate conditions depend on the selected PECB offering.
What to expect
- Training focused on ISO 13485 and the selected Foundation pathway.
- Options to explore flexible learning delivery, where available.
- Course-specific syllabus, learning outcomes, prerequisites and certification requirements confirmed before enrollment.
Foundation Training — What’s Included
Certificate and examination fees are included in the training course price.
- PECB instructional materials containing explanations, guidance, and practical examples.
- An attestation of course completion worth 14 Continuing Professional Development (CPD) credits.
- One free examination retake within 12 months if the first attempt is unsuccessful.
Benefits are subject to the applicable PECB Foundation course, participation, and delivery-format policies. Certification is awarded only after applicable requirements are met.