Intertek combines its capability to provide regulatory and analytical support with the experience of selected partners in the clinical fields, to help clients develop strategies for introducing plastic medical devices in USA, Canada and Europe.
- Developing and support in implementing Quality systems
- Developing the compliance of the material for a device from an analytical point of view
Medical Device Services:
- Restriction of Hazardous Substances (RoHS) Services
- Chemical Analysis for Medical Device Components
- Scientific Support Services for Medical Devices
- Medical Device Materials Failure Analysis
** The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.
