I will handle mhra registration, ukcra compliance and fda regulatory documentation

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stella_mandy22
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stella_mandy22
Stella M

About this gig

Are you looking for support with MHRA registration, UKCA compliance, or FDA medical device requirements?


I provide medical device regulatory support to help manufacturers, startups, importers, and businesses prepare for their target markets in the UK and USA.


My services include:

  • UK MHRA medical device registration
  • UKCA compliance and documentation support
  • FDA establishment registration and device listing assistance
  • Medical device regulatory documentation
  • Compliance reviews and gap assessments
  • UK Responsible Person requirements guidance


I work with you to understand your medical device, review the applicable requirements, and support the registration or compliance process based on your product type and target market.


Why choose my service?

  • Clear communication and organized documentation
  • Support tailored to your medical device
  • Attention to applicable regulatory requirements
  • Professional and confidential handling of your information


Kindly contact me before placing an order. Share your product type, device classification (if known), target market, and current registration status so I can confirm the appropriate service.


Get to know Stella M

Stella M

Fda compliance and eu gpsr regulatory specialist

  • FromUnited Kingdom
  • Member sinceDec 2025
  • Languages

    English
Greetings! I’m Mandy, a Regulatory Compliance & Product Safety Specialist helping businesses navigate complex global requirements. I specialize in FDA Establishment Registration, 510(k) Submissions, US Agent Representation, FSVP, Labeling Compliance, and Amazon EU GPSR Resolution. My approach is thorough and client-centric. Whether you’re launching medical devices, expanding to Europe, or fixing listing issues, I make compliance simple, accurate, and stress-free. Let’s keep your business compliant and ready to grow reach out today!