INTERNAL AUDITOR TRAINING

COURSE SCHEDULE

Course Objectives

This three-day internal auditing training on the Medical Device Single Audit Program (MDSAP) is designed to equip medical device industry professionals with the knowledge and skills required to conduct effective internal audits in accordance with MDSAP requirements. This comprehensive training covers regulatory affairs, compliance requirements, and audit techniques critical for ensuring the quality and safety of medical devices.

Course outline

Day 1

• Introduction to MDSAP and regulatory frameworkPurpose and scope of MDSAP
• Quality Management System (QMS) requirements
• MDSAP audit model and its alignment with international standards

Day 2

• Design and development

• Production and service controls

• Purchasing activities
• Device Marketing authorisation and facility registration
• MDSAP country-specific requirements
• How MDSAP integrates with individual national regulations

Day 3

• Understanding in-depth: MDSAP QMS requirements

• Key Elements of QMS:
• Risk management
• Design control
• Production processes
• Preparing for QMS audits and assessments
• Audit reporting and documentation
• Assignment and discussion
• Preparing for the examination

Who Should Attend?

• Quality Assurance, Regulatory Affairs

• Research & Development

• Operations Managers, Manufacturing Managers

• Engineers and Service Providers 

Examination & Certification

Examination is conducted on an online platform and consists of multiple-choice questions.

Exam duration: 60 minutes

Passing criteria: 60%

Participants are assessed throughout the course for punctuality, engagement, and an interactive approach. The final examination is conducted online. General evaluation requires four weeks from the submission of the final examinations. Participants who pass the final examination receive TÜV SÜD’s successful completion certificate, which indicates that the candidate has passed the examination.