In order to gain regulatory authority approvals to place medical devices on the market, equipment manufacturers must prove their products comply technically and administratively with relevant standards and gain the necessary certifications.
Different global regions and countries have different regulatory and certification requirements and gaining them can prove costly and time consuming. Eurofins Medical Device Testing’s certification services can help you earn the certifications needed to bring your Medical Devices to market .
Choose Eurofins Medical Device Testing to help you obtain:
✔ Access Global Markets efficiently and easily
✔ Gain access to Europe through our Notified Body services
✔ Gain access to the US through Eurofins MET labs NRTL services and FDA expert services
✔ Gain access to Canada through Eurofins MET labs SCC services
✔ Certify your product through the CB Scheme for compliance in over 50 countries
|Certification Services for Medical Electrical Equipment|
|Global Market Access||Notified Body (EU)||NRL & SCC (US & CAN)|
|CB Scheme||ISO 13485 Audits||MDSAP|