I will prepare mhra, ukca, fda and mdr compliance documentation

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yeesha_007
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yeesha_007
Ayeesha

About this gig

Getting a medical device or regulated product ready for MHRA, UKCA, FDA, or MDR review is one of the biggest bottlenecks founders face before launch. Missing or poorly structured documentation is the #1 reason submissions get delayed.


I prepare and structure the documentation manufacturers need to move through MHRA registration, UKCA marking, FDA compliance review, and MDR technical files, so your submission is complete, consistent, and ready for your regulatory body or Notified/Approved Body to review.


Recent example: a UK-based Class I device manufacturer came to me with a rejected UKCA application due to an incomplete technical file. I restructured their design dossier, risk management summary, and labeling documentation, and their resubmission cleared review on the next attempt.


What I do NOT do: I do not issue government certificates myself (only MHRA, UKCA Approved Bodies, and FDA can do that). I prepare the documentation, structure, and compliance groundwork that gets you submission-ready.


Message me before ordering so I can confirm scope for your device class.

Get to know Ayeesha

Ayeesha

Business formation expert

  • FromUnited Kingdom
  • Member sinceJul 2026
  • Avg. response time1 hour
  • Languages

    English, French, German
I’m a professional compliance and registration specialist helping businesses navigate U.S., UK, and EU regulatory requirements. I provide FDA registration, US Agent services, MoCRA compliance, product listing and label review, MHRA, UKCA and MDR documentation, Amazon EPR registration, and EU compliance support. I also assist trucking businesses with DOT, MC Number, BOC-3 and FMCSA registration. My goal is to make compliance simple, accurate, and stress-free while helping you avoid costly delays, penalties, and account issues.