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Regulatory Compliance

From navigating the MDR to supporting 510(k) applications with the FDA, the experienced team at Medical Design Group are here to help provide guidance and support with planning your regulatory pathway through to compliance.

We have a trusted network of regulatory consultants who are more than capable of adopting roles of a UK Responsible Person (UKRP) and EU MDR/IVDR Person Responsible for Regulatory Compliance (PRRC) and that can assist with liaising with regulators & notified bodies alike.

Ways we can help include: 

• Regulatory strategies
• Regulatory roadmaps
• Technical file management
• Conformity assessment management
• Regulatory submission management with notified body
• Registering medical devices with the MHRA

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