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Medical Devices Foundation EN · KO

ISO 13485 Foundation

Understand the fundamentals of a quality management system for medical devices with ISO 13485: QMS concepts, the regulatory context and the main requirements across the medical device lifecycle.

2 daysof training
Foundationentry level
EN · KOlanguages
OfficialPECB exam incl.

Who is this course for?

  • Professionals starting out in medical devices quality
  • Quality, regulatory and production staff
  • Consultants and managers introducing a medical devices QMS
  • Those preparing for the ISO 13485 Lead Implementer or Lead Auditor level

What you'll gain

  • The PECB Certified ISO 13485 Foundation credential
  • An understanding of QMS concepts and ISO 13485 requirements
  • Knowledge of the regulatory context of medical devices
  • A solid base to progress towards the Lead levels

Course programme

Day 1 · Introduction to ISO 13485 and management system concepts
  • Key concepts and benefits
  • The ISO 13485 framework and structure
  • Roles and responsibilities
Day 2 · ISO 13485 requirements and exam
  • Key requirements of the standard
  • Planning, operation and improvement
  • Review and official Foundation exam

Exam, credits & certification

1 h
Duration of the official PECB exam
14 CPD
Continuing Professional Development credits awarded by the course
Included
Exam, marking and first issue of the certification, included in the price

After passing the exam, you can apply for the "PECB Certified ISO 13485 Foundation" credential. The exam includes 2 attempts: the first plus a free retake, usable within the following 12 months. Passing first time is no longer a source of pressure. CPD credits correspond to the level of the course according to PECB. Exam duration is indicative; ask me for the exact details when you enrol.

Your trainer

Ricardo Coronel Lemus, PECB trainer

Ricardo Coronel Lemus

Practising GRC / vCISO consultant · PECB Certified Trainer (CT6496)

Over 20 years in cybersecurity and compliance, today a vCISO and GRC consultant with real clients in France, Spain and Mexico. I don't approach standards theoretically: I apply them day to day with real clients: that's what I bring to my coaching and exam preparation.

ISO 27001 Lead Auditor / Lead Implementer CISSPCISMCRISCCCISODORA Lead ManagerPCI DSS - PCIP

Frequently asked questions

Do I need any prerequisites?
No formal prerequisites are required to take the course. Prior background in the field helps, but is not mandatory.
What language is the exam in?
The official PECB material and exam for this course are available in the languages shown on this page. Coaching is delivered in English to prepare you thoroughly. If you need a specific language, contact us and we will confirm it.
What is the difference between Self-Study and Self-Study + Coaching?
Self-Study gives you the official material, the exam and the certification so you can progress at your own pace. The coaching option adds one-to-one sessions with me, real-world case studies and guided exam preparation: I support you until you feel ready to certify.
What if I don't pass the exam?
The PECB exam includes 2 attempts: the first plus a free retake usable within the following 12 months. So a failure doesn't leave you stranded. What's more, with the coaching option we prepare for the exam together with mock exams so that you arrive confident.
How does ISO 13485 relate to medical device regulations?
ISO 13485 is the internationally recognised quality management system standard for medical devices. A compliant QMS supports conformity with regulations such as the EU MDR/IVDR and expectations of authorities worldwide.

Ready to advance your medical devices quality career?

Choose your option above and enrol online. A question or need some advice? Write to me or book a call.

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