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 Solution:

• 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.