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I will do mhra registration, ukca certificate, fda compliance and mdr documentation
Harper
About this gig
Register Your Medical Devices in the UK, EU & USA Fast, Compliant, and Hassle-Free
Are you looking to get your medical device approved without delays or costly mistakes? I provide expert regulatory support to help you achieve full compliance in the UK, EU, and USA with confidence.
I am a seasoned Regulatory Affairs Specialist with hands-on experience in MHRA, UKCA, FDA, EMA, and MDR requirements. I work with startups, manufacturers, and Amazon sellers to deliver accurate documentation and smooth product approvals.
What youll get:
- MHRA registration (UK medical device authority)
- UKCA certification & Declarations of Conformity
- UK Responsible Person (UKRP) support
- FDA & EMA eCTD modules (15) preparation
- ISO 13485 technical documentation
- MDR, FDA, UKCA, and TGA compliance guidance
- Support for Amazon medical device compliance
Why choose me?
- Up-to-date knowledge of UK, EU, and US regulations
- Error-free, audit-ready documentation
- Fast turnaround and clear communication
- Tailored solutions for your specific product
I focus on delivering compliant, professional documentation that meets the latest regulatory standards helping you avoid rejections and get approved faster.
ORDER NOW !!!
Get to know Harper
Harper
TOP R
- FromFrance
- Member sinceMar 2026
- Avg. response time1 hour
Languages
English
I support individuals, businesses, and researchers with VAT registration, FDA registration, ITIN applications, virtual address setup, EPR registration, tax registration, and form preparation, sworn translation, I also provide professional writing and research assistance. My focus is to deliver organized, accurate, and dependable services that help clients complete their documentation and writing projects effectively.
FAQ
What information do you need to start my medical device registration?
I’ll need your product details, classification, intended use, existing documentation (if any), and target market (UK, EU, or USA). Don’t worry if you’re unsure—I’ll guide you step by step.
How long does the regulatory approval process take?
Timelines depend on your device class and region (MHRA, FDA, or EU MDR). I focus on fast, accurate preparation to avoid delays and speed up approvals.
Do you support FDA, UKCA, and EU MDR compliance for Amazon sellers?
Yes, I provide complete compliance support for Amazon and other marketplaces, including documentation, certification guidance, and regulatory requirements
