MDSAP Certification for an Indian Electro-Medical Device Manufacturer

Our Approach

• 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.
  
• DDocumentation 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.