Medical Device Services
World Leader and Innovator in Medical Device Testing and Certification
DEKRA is a world leader and innovator in the testing of medical devices for the global healthcare industry. With a global network of offices and state-of-the-art laboratories, we help our customers access worldwide markets including Europe, Taiwan, the USA, Canada, Brazil, Australia, and Japan. And we provide customers with certifications for their quality management systems in combination with CE certification.
Today’s healthcare professionals and consumers demand the highest levels of patient safety and stringent standards from manufacturers and suppliers of healthcare products and services. International rules and regulations for medical device manufacturers are becoming increasingly complex and more demanding as the level of protection of patients has to be increased and as devices become more complex and connected. Technological innovation in the healthcare industry is a growing area and faces new challenges, such as privacy issues and security threats. Patient safety is always the number one priority for healthcare professionals, which is why DEKRA’s medical device services experts are always ahead of the curve when it comes to technological innovation in the healthcare sector. Our healthcare customers demand the highest levels of expertise and knowledge in this dynamic, ever-changing industry.
DEKRA’s range of medical device services includes two Notified Bodies. We are one of the five largest Notified Bodies in the world for companies involved in the design, manufacturing, and distribution of medical devices, including high-risk and innovative medical devices and in-vitro diagnostic medical devices. Our range of services are specialized in high risk and innovative medical devices and in-vitro diagnostic medical devices, with a main focus on Class II and III devices. The service portfolio is based on:
- CE certification according to MDD (Medical Devices Directive and MDR (Medical Devices Regulation)
- CE certification according to IVDD (In Vitro Diagnostic Medical Devices Directive and IVDR (In Vitro Diagnostic Medical Devices Regulation)
- Auditing services for ISO 13485
- Auditing services according to the Medical Device Single Audit Program (MDSAP) and similar programs such as TCP
We also offer our customers a single point-of contact and comprehensive service portfolio for connected medical devices with services in testing for electrical safety, electromagnetic compatibility, interoperability, wireless, performance, usability, and cyber security. Ensure the safety and quality of your products starts with DEKRA.