Global MDSAP Certification for Indian Electro-Medical Device Manufacturer

Problem Statement:

An Indian medical device manufacturer specializing in electro-medical equipment aimed to achieve MDSAP (Medical Device Single Audit Program) certification. The certification was critical to meeting the regulatory requirements of multiple jurisdictions, including FDA (USA), Health Canada, TGA (Australia), and Japan PMDA, through a single audit. Achieving MDSAP was essential for expanding their global reach while maintaining stringent standards for quality, safety, and performance.

Our Solution:

• Quality Management System Alignment:
  D2R conducted a comprehensive assessment of the client’s existing Quality Management System (QMS) and aligned it with the regulatory requirements outlined by MDSAP. This included updates to design controls, manufacturing processes, and distribution protocols.
• Documentation and Compliance Support:
  D2R prepared and streamlined all necessary documentation, including standard operating procedures (SOPs), risk management files, and process controls, ensuring full compliance with MDSAP guidelines.
• Pre-Audit Preparation:
  To prepare for the rigorous MDSAP audit, D2R conducted mock audits to identify gaps and implemented corrective actions. These included process validations, internal audits, and detailed training sessions for the client’s team to ensure readiness.
• Audit Coordination:
  D2R coordinated with the Notified Body conducting the MDSAP audit, providing end-to-end support during the process, including addressing queries and follow-ups to ensure successful completion.

Outcome:

The company became the first Indian manufacturer of electro-medical devices to receive MDSAP certification. This prestigious certification validated the implementation and maintenance of a robust QMS across their design, development, manufacturing, and distribution processes. The MDSAP certification opened up opportunities for exporting medical devices to all member countries, including Brazil, Australia, Japan, the USA, and Canada, enhancing the company’s global credibility.