CE Certification for Surgical Dressing product
PROBLEM STATEMENT
The Indian branch of a MNC medical device manufacturer sought CE certification for Hemostat, a sterile absorbable gelatin sponge, to meet European regulatory requirements under the EU Medical Device Regulation (MDR) and expand its market reach.
Our Approach
- Prepared a comprehensive technical file, including device description, preclinical and clinical data, and risk management documentation.
- Aligned the client’s QMS with ISO 13485 to ensure compliance with EU regulatory standards.
- Conducted a detailed Clinical Evaluation Report (CER) based on clinical data and literature reviews.
- Guided the client through the conformity assessment process with a Notified Body and managed regulatory submissions.
Outcome
Hemostat successfully achieved CE certification, enabling its sale across Europe. The certification validated the product’s compliance with EU safety and performance standards, strengthening the manufacturer’s global market position.
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