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I will do mhra registration, ukca certificate, fda compliance and mdr documentation
Fully Accredited FDA Regulatory Compliance, US Market Entry Consultant
Hello, I’m Florian Anthonia, a very vibrant FDA & Regulatory Compliance Consultant helping businesses turn complex U.S. FDA requirements into clear, actionable steps. I support brands, manufacturers, ...
Informazioni su questo servizio
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.
Tipo di attività:
LLC
•
LTD
Paese di destinazione:
Tutto il mondo
•
Regno Unito
•
Stati Uniti
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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.
