Introduction to Medical Devices

Description and content:

  1. Description: This introduction to Medical Devices will bring you through the main aspects of this market. You will acquire the key concepts and requirements for Medical Devices around the world.
  2. Content:
    1. Regulatory landscape for Medical Devices in the world;
    2. The main regulations: FDA 21 CFR and EU MDD/MDR;
    3. International standards: ISO 13485, ISO 14971, IEC 14971, IEC 60601;
    4. The main regulated processes:
      1. Development of Medical Devices;
      2. Manufacturing of Medical Devices;
      3. Regulatory submissions and Post-Market activities;

Who should attend:

Professionals from other sectors considering moving into the Medical Device job market;

  1. Young graduates who want to acquire key knowledge for interviews with Medical Device companies;
  2. Entrepreneurs seeking to have a basic understanding of the Medical Device requirements, challenges and opportunities.

REGULAR CLASS

Duration: 4 hours
Price per person: 75 €
Min nr of participants: 4

ONLINE CLASS

Price per person: 60 €
Min nr of participants: 5

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