Lead Auditor Training Based on the International MDSAP Audit Approach

MDSAP Lead Auditor Training - International MDSAP Audit Approach

Course Duration: 5 Days - 8 Hours/day

This five-day training course covers the requirements of the international Medical Device Single Audit Program (MDSAP) Audit Approach, as well as the methods to audit the regulations for conformity and the requirements for Auditing Organizations. This course is intended for those who plan to become a third-party MDSAP auditor, or those serving as lead auditors of their internal audit teams.

Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. This course is designed for those that are already experienced and have been trained on ISO 13485. While the linkages to ISO 13485 requirements will be discussed, the 13485 requirements are not covered in depth. This is in line with IMDRF competency and training requirements, which require:

• 40 hours of training in quality management systems (e.g., ISO 9001) including a minimum of 8 hours dedicated to additional medical device quality management system requirements (e.g., ISO 13485)
• 32 hours of training in medical device regulations and auditing for conformity to these regulations
• 8 hours training in risk management principles, preferably related to the design of a medical device (e.g., ISO 14971)

Note: Omnex offers further training on both ISO 13485 and ISO 14971. For third-party auditors, check with your Auditing Organization for specific training requirements.

This course provides extensive practical training and hands-on exercises, which will help prepare medical device auditors to identify critical nonconformities and meet international regulatory requirements, as well as to plan, conduct, report and follow-up on QMS audits in accordance MDSAP. Auditing standards include MDSAP requirements, ISO 19011 and ISO 17021 (MDSAP auditors need to follow ISO 17021).

Participants of the training will learn from highly experienced instructors with decades of experience in medical device quality management systems.

This course will help you:

• Improve auditing skills focused on regulatory auditing
• Improve competence for MDSAP development, implementation and maintenance of a QMS that meet all MDSAP audit requirements
• Assess your own audit models and suggest improvement
• Be prepared to support an efficient MDSAP audit by your selected Auditing Organization
• Be eligible to become an MDSAP external AO auditor