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I will do mhra registration, ukca certificate, fda compliance and mdr documentation
Helen will
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:
- MHRA Registration (UK authority for medical devices)
- UKCA Certificates & Declarations of Conformity
- UK Responsible Person (UK RP) support
- FDA & EMA eCTD Modules (15)
- ISO 13485 technical documentation
- 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.
Get to know Helen will
Helen will
FDA EXPERT
- FromUnited States
- Member sinceMar 2026
- Avg. response time1 hour
Languages
English
Hi, I’m Helen, a professional expert with 6+ years experience in FDA registration, MoCRA compliance, and FDA cosmetic registration. I specialize in FDA registration, FDA cosmetic registration, MoCRA product listing, FDA agent services, and FDA renewal compliance. I help brands complete FDA registration fast, fix rejected FDA registration, and stay fully compliant with latest FDA laws. My FDA registration service is accurate, fast, and trusted by global clients. Message me now for expert FDA registration and MoCRA compliance support.
FAQ
What documents do you need from me to start?
I will need product details, manufacturer information, and any existing compliance documents (if available).
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.
