Job Description
Product reference:
https://www.amazon.co.uk/Silicone-Fasciitis-Achilles-Cushions-Absorbing/dp/B07Q2PSZFF/
I sell a silicone heel cup/orthotic device marketed for plantar fasciitis, heel pain relief and similar conditions. I need an experienced regulatory consultant to prepare a full UK-compliant Medical Device Technical File and to assist with MHRA registration, under my company name (I will be the manufacturer, not the importer).
What I Already Have
I can provide the following documents from the supplier:
✅ CE test report (covering ISO 15223-1, ISO 20417, ISO 14971, ISO 10993 checklist traits — but not a full Technical File)
✅ RoHS certificate (not really relevant but available)
✅ PU Material SDS
These do not constitute a complete Technical File or PMS/Risk/Clinical documentation.
What I Need You to Deliver
You should have demonstrable experience working with medical device regulatory compliance, EU MDR (2017/745) and UK MDR (MHRA) for Class I devices — especially orthotic/support devices with intact skin contact.
Required deliverables include (but are not limited to):
✔ Full Technical Documentation (UKCA/UK MDR-aligned)
✔ Risk Management File per ISO 14971
✔ Clinical Evaluation Report (CER) or justification
✔ Biological Evaluation Plan / TRA
✔ UK Declaration of Conformity (under my company as legal manufacturer)
✔ Product labeling and IFU compliant with ISO 20417
✔ Post-Market Surveillance (PMS) plan & templates
✔ Guidance/support for MHRA registration and submission
✔ Appointment guidance for UK Responsible Person (if needed)
✔ Any other required annexes the MHRA expects
Quality, Detail & Amazon
I need someone with great attention to detail because Amazon can and will request documentation — and any mismatches, incomplete files, or improper labeling could result in a product removal/delisting. So precision and completeness are essential.
End Goals
✅ A Technical File under my company’s name (I will be the legal manufacturer in UK).
✅ MHRA registration completed.
✅ Documentation Amazon can accept without issue.
⏱ Timeline
Please provide:
Your estimated lead time for completion
Milestones (draft, review, finalization)
How quickly you can turn this around
I need this project to be delivered as fast as possible without sacrificing quality.
Long-Term Opportunity
This could become a long-term relationship. I have many other products that will require similar Technical File creation and MHRA registration in future.
Quote Request
Please include in your proposal:
Total price for complete deliverables listed above
Lead time / delivery schedule
Examples of similar work you completed (ideally with MHRA or UKCA documentation)
Your approach to ensuring Amazon compliance
Any assumptions or additional costs
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