I will do mhra registration, ukca certification and UK medical device compliance

Are you a medical device manufacturer looking to legally sell in the UK market? I specialise in end-to-end MHRA registration, UKCA certification, and full UK regulatory compliance so you can focus on your product while I handle the paperwork.

What I offer:

• MHRA device registration via the DORS portal (Class I, IIa, IIb, III)
• UKCA certificate support and UK MDR 2002 compliance
• UK Responsible Person (UKRP) designation for non-UK manufacturers
• GMDN code identification and GMDN Level 2 category mapping (critical for new 2026 annual fee model)
• Technical documentation review (Declaration of Conformity, labelling, PMS)
• CE to UKCA transition support
• IVD registration (In Vitro Diagnostic devices)
• EU MDR / EUDAMED registration guidance
• FDA 510(k) and FDA compliance documentation
• Post-Market Surveillance (PMS) plan preparation

Whether you're registering a brand-new device or managing the 2026 DORS annual fee changes, I have the regulatory expertise to keep you compliant and your products on the market.

Message me before ordering to confirm your device class and country of manufacture I respond within the hour.