ISO 13485: PECB Medical Devices Quality Management Training
The quality standard for manufacturers, distributors and suppliers of medical devices. Self-Study on request for Greece, Cyprus and Europe.
- Foundation, Lead Implementer, Lead Auditor
- Self-Study on request
- Greece, Cyprus & Europe
What is ISO 13485
ISO 13485 sets out the requirements for a quality management system specific to medical devices, from design and production to storage, distribution and servicing.
It emphasises risk management, traceability and compliance with the EU Medical Device Regulation (EU) 2017/745 (MDR).
Why it is worth it
- A base for MDR compliance.
- Essential for EU market access.
- Patient safety and traceability.
- Trust from hospitals and distributors.
PECB ISO 13485 training levels
Choose a level by your role and experience. Each brochure opens on the PECB website.
ISO 13485 Foundation
Key concepts, principles and requirements of ISO 13485, with no prerequisites.
ISO 13485 Lead Implementer
Plan, implement, manage and improve a medical devices quality management system based on ISO 13485.
ISO 13485 Lead Auditor
Plan and conduct audits of a medical devices quality management system based on ISO 19011 and ISO/IEC 17021-1.
How to get started
The ISO 13485 courses are not yet in our shop, but they are available as PECB Self-Study on request. Contact us for availability and a quotation.
ISO 13485 frequently asked questions
Which ISO 13485 course should I choose?
If you are starting out, Foundation. If you will implement or coordinate the system, Lead Implementer. If you will audit, Lead Auditor. We can recommend the right level for your role.
In which format are the courses available?
As PECB Self-Study, with the official PECB manual, self-paced with an online exam.
What language are the material and exam in?
English. Support from Greece Lean Six Sigma is available in Greek or English.
Are the exam and certification included?
Yes. The first exam attempt, one free retake within 12 months and the certification fee are included.
Want to make ISO 13485 work in practice?
We combine PECB certification with Lean Six Sigma and Operational Excellence so the system delivers measurable results.