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I will do mhra registration ukca certificate mdr documentation and fda compliance
Zara Mitchell
About this gig
Do you need to register your medical device with the MHRA and place it legally on the UK market but find the process complex and confusing?
I provide full MHRA registration support, UKCA certification, MDR technical documentation, and UK Responsible Person services for medical device manufacturers entering or operating in the UK market.
What I handle:
- MHRA medical device registration (Class I, IIa, IIb, III)
- UKCA certificate preparation and conformity assessment
- UK MDR 2002 technical documentation and DoC
- UK Responsible Person (UKRP) appointment service
- EU MDR CE marking documentation on request
- FDA 510(k) and FDA registration guidance
- IVD (In Vitro Diagnostic) device registration
- ISO 13485 quality management system guidance
- Vape and nicotine product MHRA registration
- Food supplement MHRA and FSA compliance
Why buyers choose me:
- Covers UK, EU, and FDA in one complete package
- Handles Class I through Class III devices
- Fast turnaround with full revision support
- Strict confidentiality on all technical documents
Selling an unregistered medical device in the UK carries serious legal penalties and market withdrawal risk.
Get to know Zara Mitchell
Zara Mitchell
bid expert
- FromUnited States
- Member sinceMay 2026
Languages
English
I help businesses win contracts, get licensed, and launch with confidence.
I specialise in UK tender and bid proposal writing healthcare, NHS, cleaning, domiciliary care, construction, and government contracts delivering scoring-criteria-aligned responses that win.
Beyond tenders, I handle full business setup: company formation, assisted living and group home licensing, policy and procedure manuals, and compliance documentation for regulated industries.
One expert. Tenders written. Businesses built.
FAQ
What types of medical devices do you handle?
I cover Class I, IIa, IIb, and III medical devices, IVDs, active implantable devices, vape products, and food supplements requiring MHRA registration.
Do I need a UK Responsible Person if I am based outside the UK?
Yes any manufacturer outside the UK must appoint a UKRP for MHRA registration, which I provide in the Standard and Premium packages.
Do you handle EU MDR CE marking as well?
Yes EU MDR CE marking documentation is included in the Premium package, covering both UK and EU market entry in a single order.
What documents do I need to provide?
Your device description, intended purpose, classification evidence, and any existing technical files I guide you through a checklist after ordering.
Can you help with food supplement MHRA compliance?
Yes I handle UK food supplement registration, MHRA notification, and FSA food business compliance alongside medical device registration.
Do you cover FDA registration for the same device?
Yes FDA device registration and 510(k) guidance is included in the Premium package so you can register across UK, EU, and USA in one order.
