I will prepare eu mdr technical documentation, ce marking compliance for medical device

Are you bringing a medical device to the European market and need professional EU MDR compliance support?

I help manufacturers, startups, and distributors create the exact documentation required for CE Marking quickly, accurately, and fully aligned with EU MDR (2017/745).

I do not issue CE marking (only Notified Bodies can), but I prepare everything you need to pass technical documentation review and move confidently through the CE compliance process.

WHAT I OFFER

• U MDR-Compliant Technical Documentation Creation
• Technical File / Technical Documentation (TD)
• General Safety & Performance Requirements (GSPR) Checklist
• Risk Management File (ISO 14971 aligned)
• Clinical Evaluation Report (CER) literature-based
• Post-Market Surveillance (PMS) Plan
• Post-Market Clinical Follow-up (PMCF) Plan
• IFU / Labeling Review for EU MDR
• EU Declaration of Conformity (template + guidance)
• ️ EUDAMED Guidance & Support
• Manufacturer registration support
• UDI / Basic UDI-DI documentation guidanc
• QMS Documentation (Optional Add-On)
• ISO 13485 starter template
• SOPs for regulatory, PMS, risk, and design control

Lets get your medical device ready for compliant, successful European market entry.

Order now or messag