You will get EU MDR Technical Documentation Package for Medical Device Startups
Rising Talent
Rising Talent
Project details
Most MedTech startups face a choice: pay 150-300 EUR/hour for a traditional regulatory consultant, or struggle through EU MDR documentation alone with no regulatory background. I built a different option.
I combine genuine regulatory credentials — a Doctor of Pharmacy (PharmD) and MSc in Pharmaceutical Regulatory Affairs, with hands-on ISO 13485 experience at Siemens Healthineers Ireland — with an AI-assisted documentation system built specifically for EU MDR compliance. This lets me deliver professional technical documentation in days, not weeks, at a fraction of consulting rates.
Every document follows the exact EU MDR Annex II/III structure, cited to specific Articles and harmonised standards, and is personally reviewed and validated by me before delivery. Nothing reaches you as final without expert human oversight — that distinction matters where AI-only output carries real compliance risk.
Built for founders, engineers, and product managers who need to understand their regulatory obligations and get a credible head start on their technical file.
I combine genuine regulatory credentials — a Doctor of Pharmacy (PharmD) and MSc in Pharmaceutical Regulatory Affairs, with hands-on ISO 13485 experience at Siemens Healthineers Ireland — with an AI-assisted documentation system built specifically for EU MDR compliance. This lets me deliver professional technical documentation in days, not weeks, at a fraction of consulting rates.
Every document follows the exact EU MDR Annex II/III structure, cited to specific Articles and harmonised standards, and is personally reviewed and validated by me before delivery. Nothing reaches you as final without expert human oversight — that distinction matters where AI-only output carries real compliance risk.
Built for founders, engineers, and product managers who need to understand their regulatory obligations and get a credible head start on their technical file.
Field of Law
Health & MedicalTarget Country
Worldwide, United Kingdom, GermanyLanguage
English, IrishService Type
Legal Assistance, Legal Writing, Documentation Review, Contracts, Trademark RegistrationWhat's included
| Service Tiers |
Starter
$149
|
Standard
$299
|
Advanced
$499
|
|---|---|---|---|
| Delivery Time | 2 days | 3 days | 5 days |
Number of Revisions | 1 | 2 | 3 |
Frequently asked questions
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Alona B.
Jul 1, 2026
Ireland Videoproject - Online video and video in the store – Share Your Shopping Experience
High-quality work delivered quickly. Great communication throughout the project.
About Hameed Faheem
PharmD | EU MDR Regulatory Affairs Consultant | GMP | ISO 13485
Dublin, Ireland - 2:03 pm local time
I help MedTech startups navigate EU MDR compliance faster and more affordably by combining genuine regulatory expertise with AI-assisted documentation workflows. Where traditional consultants charge €150-300/hour, I deliver professional technical documentation in days, with every output personally reviewed and validated against EU MDR Annexes, harmonised standards, and current MDCG guidance.
I work across three areas:
EU Regulatory Affairs & AI-Assisted Documentation
EU MDR classification analysis, technical file structuring (Annex II/III), ISO 14971 risk management plans, GSPR checklists, and clinical evaluation frameworks — generated through AI-assisted workflows and validated by my regulatory training and hands-on EU MDR/IVDR experience.
Quality & Compliance
ISO 9001 and ISO 13485 QMS development, SharePoint document management systems, CAPA tracking, policy and procedure writing, training matrices, and audit preparation. I have built these systems from scratch in live regulated environments.
Technical & Regulatory Writing
SOPs, technical files, GMP documentation, medical device technical documentation, and explainer content for pharma and healthcare audiences. I write from real industry experience, not research alone.
My background spans regulated homecare, ISO 13485 medical device manufacturing, EU cGMP pharmaceutical packaging, and postgraduate regulatory education covering EU MDR, EU IVDR, pharmacovigilance, and regulatory submissions.
Whatever the project, my proficiency is in accuracy, structure, and clear professional output — the same discipline required in environments where precision is not optional.
Steps for completing your project
After purchasing the project, send requirements so Hameed Faheem can start the project.
Delivery time starts when Hameed Faheem receives requirements from you.
Hameed Faheem works on your project following the steps below.
Revisions may occur after the delivery date.
Client Intake & Classification
I run a structured intake covering your device, intended use, and clinical claims, then determine your preliminary EU MDR classification with regulatory rule citations.
Document Generation
I generate your selected technical documentation package using AI-assisted drafting referenced to EU MDR Annexes and harmonised standards.