I will prepare your eu mdr technical documentation for ce marking

Need CE marking under the EU Medical Device Regulation? MDR requires detailed technical documentation, and incomplete files are a leading cause of Notified Body delays and rejections.

I help you build a clear, audit-ready file so your review goes smoother.

WHAT'S INCLUDED

Gap analysis against MDR 2017/745

Device classification check (Annex VIII rules)

Technical documentation structure (Annex II and III)

General Safety and Performance Requirements (GSPR) checklist

Labeling and IFU review

Risk management file support (ISO 14971)

Clinical evaluation outline and PMS plan (Premium)

EU declaration of conformity draft (Premium)

WHO IT'S FOR

Manufacturers moving from MDD to MDR

Non-EU manufacturers entering Europe

Start-ups preparing for a Notified Body review

HOW IT WORKS

1. Message me your device and current documents

2. I confirm the scope and package

3. Send your files

4. I review, structure and prepare your documentation

Message me before ordering so I can scope it correctly.