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.

Case Studies

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CE Certification for Surgical Dressing product

PROBLEM STATEMENT

Our Approach

Outcome

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