Introduction to ISO 13485

Description and content:

  1. Description: Introductory course to ISO 13485. You will be presented with an overview of the ISO 13485 standard and main requirements of a Quality System for Medical Device companies.
  2. Content:
    1. Application of ISO 13485 in different jurisdictions;
    2. Overview of ISO 13485;
    3. Step-by-step on main clauses;
    4. How to build a compliant QMS;
    5. Examples and workshop;

Who should attend:

  1. Professionals from other sectors considering moving into the Medical Device job market;
  2. Young graduates who want to acquire key knowledge for interviews with Medical Device companies;
  3. Companies entering the Medical Device market.


Duration: 4 hours
Price per person: 180 €
Min nr of participants: 4


Price per person: 120 €
Min nr of participants: 5

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