Join us for a comprehensive and informative event focused on the medical device industry’s regulatory requirements and quality management systems.
This event is ideal for professionals involved in medical device development, manufacturing, and compliance.
We will cover essential topics such as UL/CSA/IEC 60601-1 medical requirements, ISO 13485 Quality Management Systems (QMS) implementation, the latest changes in Medical Device Regulations (MDR) for FDA, Health Canada, UK, and EU (CE), and the Risk Management Framework (RMF) based on ISO 14971:2019.
- UL/CSA/IEC 60601-1 medical requirements
- ISO 13485 QMS – Crawl, Walk & Run
- MDR changes for Medical Devices – FDA, Health Canada, UK and EU (CE).
- Risk Management (RMF) – ISO 14971:2019
Venue: Centech (Accueil – Centech) -1000 rue Saint-Jacques, office C-0131, Montreal (Quebec) H3C 1G7
Time: Sept. 22, 2023, 9am to 1PM
Cost: $50 CAD