In May 2017, the European Commission voted to approve new Medical Device Regulations (2017/745). This is one of the most significant updates of the regulations that govern medical devices in Europe in recent history.
The transition to the new MDR can be overwhelming if you do not have the resources required to support it. This is where Oxford can partner with you! Through our established network of compliance experts within the device sphere, we can support clients of all sizes – from start-ups to multinational market leaders. We can provide recruiting and consulting support for every stage of the MDR compliance transition process.
For information on the new Medical Device Regulations (MDR) click here.
OXFORD’S MDR PROCESS
Define Scope of Work
MDR Compliance Checklist
MDR Compliance Training
Mock Inspection & Stress Testing
Migration to MDR Compliance
- Compliance experts in medical devices, ISO 13485 and 14971 and the newly published MDR
- Experts in Technical File and CER compilation for all classes of medical devices
- Specific device product knowledge from Orthopaedic to Cardiovascular, Drug Delivery, Software Devices and IVDs
- Lead auditor consultants who have held senior positions for notified bodies and regulatory agencies such as the FDA
- Consultants who have held manager and director level positions for many of the major manufacturers within medical devices
For more information on how we can help you transition to the new MDR contact Oxford today!