I will do uk mhra registration ukca certificate mdr documentation

Adex O

United States

I speak English

Regulatory Specialist

Welcome to Opticore Solution, your trusted partner in global healthcare and medical device regulatory compliance. Navigating the UK Medicines and Healthcare products Regulatory Agency (MHRA) guidelin...
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About this Gig

Are you launching a medical device, IVD, or healthcare product in the UK market?


Navigating post-Brexit regulatory requirements can be challenging. To sell legally in Great Britain, non-UK manufacturers must appoint a UK Responsible Person (UKRP), register with the MHRA, and maintain full UKCA/MDR technical documentation.


I provide end-to-end Regulatory Affairs consulting to ensure your product meets all MHRA guidelines, UKCA standards, and EU MDR/IVDR framework requirements quickly and seamlessly.


SERVICES INCLUDED IN THIS GIG:

  • MHRA Account Setup & Device Registration (Class I, IIa, IIb, III & IVD)
  • UK Responsible Person (UKRP) Strategy & Verification
  • UKCA & CE Marking Compliance Audit
  • Technical File Preparation & GSPR (General Safety and Performance Requirements)
  • EU MDR 2017/745 & IVDR 2017/746 Gap Analysis
  • Declaration of Conformity (DoC) Drafting
  • Labelling, IFU (Instructions for Use), & Symbol Compliance Reviews


Send a direct message now with your product details for a custom evaluation!

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