ISO 13485 MDMS Lead Auditor


The ISO 13485 Medical Device Management Systems Lead Auditor Certification provides individuals with the essential knowledge and skills to audit medical device management systems based on ISO 13485 standards. Participants will acquire a deep understanding of quality management principles specific to the medical device industry, enabling them to assess compliance with regulatory requirements and ensure the production of safe and effective medical devices. By completing this course, individuals will be proficient in identifying, assessing, and mitigating risks associated with medical device manufacturing, thereby enhancing product quality and patient safety.

Certification Authenticity

This certification is recognized across the world (Asian Countries, Gulf-UAE, Qatar, Saudi Arabia, Bahrain, Kuwait, Europe, USA etc. for the Medical Device Internal and Lead Auditors.

Learning outcomes

  1. Overview of Medical Device Management Systems (MDMS)
  2. Responsibilities of a Lead Auditor
  3. Planning and Preparing for MDMS Audits
  4. Conducting MDMS Audits
  5. Reporting Findings and Driving Continuous Improvement in Medical Device Management Systems.

Key Benefits

  • Comprehensive Understanding of Quality Management Principles for Medical Devices
  • Proficiency in Conducting Audits of Medical Device Management Systems
  • Improvement in Resource Efficiency and Cost Reduction through Effective Quality Management Practices
  • Enhanced Compliance with Regulatory Requirements for Medical Devices
  • Strengthened Stakeholder Trust and Reputation in Medical Device Safety and Quality.
Training DurationMode of Training
 05 DaysOnline/ Class Room

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