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

Define timelines and scope of work that is tailored to your organization’s size, class of device and budget.
 

Gap Assessment

Identify gaps and weak points and provide a project plan with milestones for transition to MDR compliance.
 

MDR Compliance Checklist

Give guidance and expert advice on all of the key changes of the MDR including post market surveillance, the role of the responsible person, CER’s MEDDEV 2.7.1 Rev 4.
 

MDR Compliance Training

Provide tailored training programs based on your company’s size, class of device, level of management from corporate to mid-level team leaders.
 

Mock Inspection & Stress Testing

Provide ad-hoc support to test the level of compliance & audit readiness by certified lead auditors with regular checks on the manufacturing processes & technical files for established & newly launched devices.
 

Migration to MDR Compliance

Support migration to MDR compliance while taking into consideration other needs – OSP 13485:2016, MDSAP.
 

OXFORD’S EXPERTS

  • 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!