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Nederlands
$
USD
I will prepare mhra, ukca, fda and mdr compliance documentation
Ayeesha
Over deze dienst
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.
Maak kennis met Ayeesha
Ayeesha
Business formation expert
- Afkomstig uitVerenigd Koninkrijk
- Lid sindsjul 2026
- Gem. reactietijd3 uur
Talen
Engels, Frans, Duits
Unlock seamless business formation in the UK & US! With a wealth of experience, I provide expert guidance and comprehensive services for LLCs, Corporations, EIN/Tax IDs, Registered Agent services, and Operating Agreements. From initial setup to full compliance, I ensure your venture starts strong. Let's build your business foundation together!
Veelgestelde vragen
Q1: Do you issue the actual MHRA, UKCA, or FDA certificate?
No. Only MHRA, a UK Approved Body, or the FDA can issue the actual certificate or clearance. I prepare, structure, and review the technical and regulatory documentation your submission needs (technical files, risk mgt summaries, registration docs, etc), so it's complete and ready for their review.
Q2: What device classes do you work with?
I work with Class I, IIa, IIb, and III medical devices, as well as general regulated products needing FDA compliance documentation. Tell me your device classification when you message me, and I'll confirm the right package and timeline for your case.
Q3: What information do you need from me to start?
I'll need your product/device description and intended use, current classification (if known), target market(s), any existing technical documentation, and your current stage in the certification process. See the Requirements section for the full list.
Q4: Can you handle documentation for multiple markets at once (US, UK, EU)?
Yes. The Premium package is built for exactly this. I structure documentation so your MHRA/UKCA, MDR, and FDA compliance files are aligned instead of built separately, which saves time and reduces inconsistency across submissions.
Q5: How long does the process take?
Basic delivers in 5 days, Standard in 8, and Premium in 12. Timelines depend on how complete your existing documentation is. If you need faster turnaround, add the 48-hour rush add-on.
Q6: Is my product/company information kept confidential?
Yes. All documents and product details you share are handled confidentially and are not reused or shared with any third party.
