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I will repair technical documentation and technical files for medical device
Medical Device Regulatory Documentation Specialist Profile Description
Hello, I am Samuel, a biomedical engineering graduate and regulatory specialist helping med-tech companies clear compliance hurdles. I specialize in reviewing, repairing, and auditing medical device t...
About this Gig
Is a non-conformity notice holding back your medical device? Regulators are tougher than ever, and a single mistake in your technical file can cause costly delays.
I bring hands-on experience in biomedical engineering and regulatory compliance to audit, edit, and repair your medical device technical documentation, ensuring full compliance with EU MDR 2017/745, FDA guidelines, and ISO standards.
What I Can Repair & Review:
- Technical Files & Design Dossiers
- GSPR Checklists (General Safety & Performance Requirements)
- ISO 14971 Risk Management Files & FMEA
- Instructions for Use (IFU), Labeling & Packaging
- ISO 13485 QMS SOPs & Gap Analyses
- Post-Market Surveillance (PMS) Plans
Why Choose This Service?
- Human-written, precise, and practical regulatory language.
- Detailed audit trail and clear formatting.
- Confidentiality-first approach with signed NDAs upon request.
Don't risk submission rejections due to formatting or compliance errors. Message me today with your project details, and let's make your technical file fully audit-ready.
Delivery style preference
Please inform the freelancer of any preferences or concerns regarding the use of AI tools in the completion and/or delivery of your order.
FAQ
What details do I need to provide before we start?
Please share your current draft document, device classification, target market (FDA, EU MDR, UKCA), and any specific feedback from your notified body or auditor.
Can you handle confidential technical files?
Absolute confidentiality is guaranteed. I am happy to sign a Non-Disclosure Agreement (NDA) before reviewing your proprietary files.
Do you write technical files from scratch?
This gig focuses on reviewing, editing, and repairing existing technical files. If you need a brand-new file compiled from scratch, please message me for a custom offer.
Which regulatory bodies do you format documentation for?
I format and repair technical files according to US FDA 510(k), EU MDR 2017/745, UKCA (MHRA), and ISO 13485/14971 standards.
What formats will I receive the final files in?
You will receive fully editable Microsoft Word (.docx) files with tracked changes, along with a finalized clean PDF version ready for submission.
How do you handle notified body non-conformity findings?
Simply send over the audit deficiency report, and I will align your documentation directly to satisfy the specific clauses raised by the auditor.
What types of medical devices do you cover?
I cover Class I, Class IIa, and Class IIb medical devices, including software as a medical device (SaMD), diagnostic tools, and physical health instruments.
Is this work generated by AI?
No. Medical regulatory files require precise engineering accuracy, technical terminology, and standard alignment that AI cannot reliably produce. Every edit is manually crafted.
What if my file is longer than the package page limits?
No problem at all! Contact me directly, and I will issue a custom quote tailored to your exact document length and complexity.
Do you guarantee regulatory approval?
While no consultant can guarantee a regulator's final decision, I ensure your documentation meets all mandatory structure and clause requirements to pass initial completeness checks.
