Expert group
Quality Management
Manufacturers, suppliers and service providers in the medical technology industry generally operate a quality management system pursuant to ISO 13485 to fulfil the regulatory requirements. ISO 13485 mainly focuses on the application of CAPA measures, the continuous guarantee of traceability and change control, the implementation of risk management in compliance with the standards, as well as the consistent use of training and document management.
Who we are
The expert group Quality Management provides its members with a platform for exchanging experiences and knowledge on the quality management system pursuant to ISO 13485 as well as 21 CFR 820. The members of the expert group manufacture their own medical devices or work as a manufacturing partner or service provider in medical technology.
Who can participate
Employees of Swiss Medtech member companies with expertise in the field of Quality Management (QM) or who are interested in QM matters.
Our goals
- Promoting the level of knowledge in the Swiss medical devices industry in the field of process, risk and quality management
Our activities
- Organising the exchange of knowledge and experiences through expert group meetings
- Forming and operating thematic working groups
- Coordinating and collaborating the expert group’s activities with the Office of Swiss Medtech and other expert groups