CE Technical File: Hemostatic Sponge
Budget: ₹1,500 – ₹12,500 INR
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.
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.