I will handle mhra registration, ukca certificate, fda compliance and mdr documentation

Are you launching a medical device in the UK, US, or European market? Navigating regulatory compliance like MHRA, FDA, UKCA, and EU MDR can be complex. I provide expert regulatory documentation and registration support to ensure your product meets all legal standards smoothly and without costly delays.

What I Offer:

1. UK Market Access: MHRA DORS device registration assistance, UK Responsible Person (UKRP) guidance, UKCA Technical File creation, and UK MDR 2002 compliance.

• US Market Access: FDA Establishment Registration, Device Listing (DRLM), 510(k) preparation support, and US Agent guidance for foreign manufacturers.
• EU & MDR Support: EU MDR (2017/745) technical dossiers, Risk Management Files (ISO 14971), Declaration of Conformity (DoC), and CER drafting.

Why Work With Me?

• Audit-ready, fully compliant documentation.
• Fast, structured, and precise service.
• End-to-end guidance from classification to submission.

Note: Government submission fees (such as FDA/MHRA direct costs) are paid directly to authorities by the client.

Please message me with your device details before placing an order!