CE Technical File: Hemostatic Sponge

I have developed a bleeding-prevention (hemostatic) sponge and now need a complete, MDR-ready technical file so we can move forward with CE marking. The design verification testing is done and I can supply test reports, drawings and manufacturing details; what I am missing is the structured documentation that will convince the Notified Body. Your main focus will be technical file preparation, specifically: • Device Description & Specifications – a clear, ISO-compliant dossier covering intended use, design details, materials, packaging and manufacturing flow. • Risk Management Documents – full ISO 14971 process from hazard identification to the final risk management report, with traceability to design controls and verification evidence. I will provide existing lab data, raw test results and any additional background you need. You will draft, refine with me, and deliver the final package in editable Word/Excel plus a bookmarked PDF, ready for internal audit and eventual submission. Acceptance criteria – File follows EU MDR Annex II & III structure. – Consistent terminology and numbering throughout. – Risk tables show likelihood / severity scoring and residual risk evaluation. – Package passes my internal audit checklist. If you have hands-on experience preparing technical files for wound-care or similar hemostatic devices, please outline it in your proposal. I’m eager to get this sponge one step closer to market with your help.

Project ID: 40470155