INTRODUCTION TO ISO 13485
Description and content:
- 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.
- Content:
- Regulatory landscape for Medical Devices in the world;
- The main regulations: FDA 21 CFR and EU MDD/MDR;
- International standards: ISO 13485, ISO 14971, IEC 14971, IEC 60601;
- The main regulated processes:
- Development of Medical Devices;
- Manufacturing of Medical Devices;
- Regulatory submissions and Post-Market activities.
- FROM 60€
- 4 hours
Who should attend:
- Professionals from other sectors considering moving into the Medical Device job market;
- Young graduates who want to acquire key knowledge for interviews with Medical Device companies;
- Entrepreneurs seeking to have a basic understanding of the Medical Device requirements, challenges and opportunities.
MINIMUM 5 PARTICIPANTS (60€ / PERSON)
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