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 Quality System Regulation (Medical Devices). The members of the expert group manufacture their own medical devices or work as a manufacturing partner or service provider in medical technology.
- Promoting the level of knowledge in the Swiss medical devices industry in the field of process, risk and quality management
- Ensuring the specific interests of the industry vis-à-vis the regulatory authorities and standards associations
- Contributing towards the establishment and further development of quality management systems in collaboration with the relevant expert committees
- Organising the exchange of knowledge and experiences through expert group meetings, seminars and conferences
- Forming and operating thematic working groups
- Coordinating and collaborating the expert group’s activities with the Office of Swiss Medtech and other expert groups