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I will do mhra registration, ukca certificate, fda compliance and mdr documentation
ISO Compliance, Medical Device Regulatory, Food Safety Documentation Expert
Regulatory compliance is the foundation of a safe, successful, and globally competitive business. I help companies achieve ISO certification, FDA compliance, CE Marking, MDR compliance, HACCP, GMP, an...
About this Gig
Looking to register your medical devices in the UK, EU, or USA with full regulatory compliance? You're in the right place!
I am a Regulatory Affairs Specialist with extensive experience in MHRA, UKCA, FDA, EMA, and MDR compliance. I help businesses meet regulatory requirements, prepare accurate documentation, and achieve smooth approvals for medical devices, cosmetics, and healthcare products.
Services I provide:
- FDA & EMA eCTD Modules (15)
- ISO 13485 technical documentation
- MHRA Registration (UK authority for medical devices)
- UKCA Certificates & Declarations of Conformity
- UK Responsible Person (UK RP) support
- EC Certificate of Conformity
- Regulatory compliance for MDR, FDA, UKCA, TGA, and Amazon devices
I ensure all documentation is clear, compliant, and professionally prepared to meet the latest UK, EU, and US regulatory standards.
Whether you're a startup, manufacturer, or Amazon seller, Ill help you achieve certification and compliance efficiently.
Type of Business:
LLC
•
LTD
Target country:
Worldwide
•
United Kingdom
•
United States
Service type:
Registered agent services
•
Compliance monitoring
Business formation & registration Gigs are not screened
Fiverr does not pre-screen freelancers offering services in Business Formation & Registration. We advise thoroughly reviewing freelancer profiles, asking questions, and confirming their qualifications to ensure they meet your requirements. Freelancers marked as “Pro” have completed a vetting process for added confidence. Learn more here.
My Portfolio
FAQ
Can you act as my UK Responsible Person (UK RP)?
Yes, I provide UK RP support as part of the service or through a tailored package.
Do you guarantee MHRA/FDA approval?
While I ensure full compliance and accurate documentation, final approval always depends on the regulatory authority.
Can you also help with Amazon device compliance?
Yes! I prepare regulatory documents required for Amazon product listings.
Do you work with both medical devices and cosmetics/food?
Yes, I specialize in medical devices but also provide compliance documentation for cosmetics and food where UK/EU regulations apply.
What information do I need to start my MHRA registration?
You need your device classification, GMDN codes, and technical documentation ready for review to ensure a smooth submission.
Can a NON-UK manufacturer register directly with the MHRA?
No. If you are outside the UK, you MUST appoint a UK Responsible Person (UKRP) to handle the registration on your behalf.
How long does the MHRA registration process actually take?
While I complete the submission within days, the MHRA usually takes 5 to 10 working days to process and issue your confirmation.
Will you help with UKCA marking requirements?
Yes. I ensure your MHRA registration aligns with current UKCA marking standards for medical devices and IVDs.
