CE marking is the regulatory requirement for medical devices to be sold in Europe.
There are three European CE marking directives that specifically apply to medical devices manufacturers:
- The Medical Devices Directive (MDD) applies to all general medical devices.
- The Active Implantable Medical Devices Directive (AIMDD) applies to all active devices implanted in human body.
- The In Vitro Diagnostics Directive (IVDD) applies to all devices and kits which is used away from the patient to diagnose the patient's medical conditions.
Our ONLINE Service includes the following.
- Documentation ( Including the preparation of Technical File)
- Testing of devices at associated laboratories across the Globe.
- Coordinate with Notified Bodies until issue of certificate.
- ISO 13485 Implementation support including document preparation.
- Risk Analysis.
- For Software medical devices ISO 62304 Implementation.
- Label drafting.