ISO 13485:2016 specifies a quality management system requirement where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Maintaining compliance with ISO 13485:2016 requirements ensures the manufacturer’s efficiency in the following areas:
- Product safety by having work environment controls in place
- Conduct proper risk management and design controls during new product development activities
- Demonstrate compliance to mandatory regulatory requirements in their jurisdiction, such as those enforced by the U.S. Food and Drug Administration (US FDA 21 CFR, part 820) and the European Union (93/42/EEC directive)
As an ISO 13485-certificated facility, Thygesen is proud to cover all the above regulatory requirements. We take quality very seriously and commit to providing services and products that meet international standards.