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$
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I will guide your medical device through ce, fda, or ukca certification
Julie D
About this gig
Getting a medical device certified feels overwhelming the regulations are complex, the paperwork is extensive, and one wrong step can cost you months and thousands of dollars.
That's where I come in.
I am a medical device regulatory specialist with hands-on experience guiding devices through CE marking (EU MDR), FDA 510(k) clearance, and UKCA certification.
WHAT I WILL DO FOR YOU
- Determine the correct classification of your device (EU MDR, FDA, UKCA)
- Identify the right certification pathway for your target market
- Build a clear, realistic roadmap with milestones and timelines
- Perform a gap analysis against applicable standards (ISO 13485, ISO 14971, IEC 62304)
- Advise on required technical documentation and clinical evidence
- Guide you on Notified Body selection or FDA submission strategy
- Flag risks early so you avoid costly delays
WHO THIS IS FOR
- Startups bringing a first device to market
- Manufacturers expanding into the EU, US, or UK
- Teams that received a major non-conformity or FDA rejection
- Companies transitioning from CE marking to UKCA post-Brexit
I have guided devices across diagnostics, orthopaedics, wearables, digital health (SaMD/AI), and Class II/III implantables.
Get to know Julie D
Julie D
Us import Consultant
- FromUnited States
- Member sinceApr 2026
Languages
English
I help food businesses, manufacturers, and importers comply with FDA requirements for the U.S. market. My services include FDA Food Facility Registration, FSVP compliance, U.S. Agent support, FCE/SID filings, label reviews, and import readiness assistance. I work with domestic and foreign facilities to help ensure smooth FDA compliance and market entry.
Other Regulatory Compliance Consulting Services I Offer
FAQ
I don't know which certification my device needs, is that okay?
Absolutely, this is exactly what I help with. Just describe your device and target market when you order and I will determine the correct classification and pathway for you.
Can you help if my device was rejected by a Notified Body or the FDA?
Yes. I regularly support teams in remediation after a major non-conformity or FDA rejection. These cases are typically handled under the Standard or Premium package. Message me with details before ordering so I can scope the work
My device is software — do you cover SaMD and AI/ML regulations?
Yes. I cover SaMD classification under EU MDR Annex VIII, FDA's Software as a Medical Device guidance (including the AI/ML action plan), and IEC 62304 compliance requirements.
We are transitioning from CE marking to UKCA after Brexit, can you help?
Yes, this is a common situation. I will map out the differences between your existing CE technical file and what UKCA/MHRA requires, and give you a clear transition roadmap.
