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I will handle mhra registration, ukca marking, and product compliance documentation
Regulatory Compliance Expert
Regulatory compliance specialist helping brands navigate complex market-entry requirements with speed and accuracy. I assist with FDA Food Facility Registration, U.S. Agent services, label review comp...
About this Gig
Are you looking to sell your products in the UK or EU market but feeling overwhelmed by regulatory requirements? I provide expert consultancy and documentation services to ensure your products meet all legal standards for UKCA marking, CE marking, and MHRA registration.
With the post-Brexit transition, having the correct Declaration of Conformity (DoC) and Technical Files is mandatory for platforms like Amazon, eBay, and TikTok Shop. I help manufacturers and importers navigate these complexities quickly and efficiently.
Services I Offer:
- MHRA Registration: For medical devices and IVDs in the UK.
- UKCA & CE Marking: Preparation of technical documentation.
- Declaration of Conformity: Creating legally compliant DoC certificates.
- Regulatory Gap Analysis: Reviewing your product labeling and safety data.
- Amazon & E-commerce Compliance: Solving "Product Safety" listing suppressed issues.
Why Choose Me?
- In-depth knowledge of UK MDR 2002 and EU MDR/IVDR.
- Fast turnaround and professional communication.
- Step-by-step guidance for non-UK residents.
FAQ
1. What information do I need to provide?
I will need your product specifications, existing test reports (if any), and company details. For medical devices, I’ll need the device classification.
2. Does this include the actual testing?
No, I provide the regulatory documentation and consultancy. Physical lab testing must be done by a certified body, but I can guide you on which tests are required.
3. Will this work for Amazon UK compliance?
Yes. I specialize in preparing the specific Declaration of Conformity and labeling requirements that Amazon requests to reinstate or approve listings.
