Internal Auditing Training on Medical Device Single Audit Program (MDSAP)

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.

Day 1

• Introduction to MDSAP and regulatory framework
• Purpose 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

• Quality Assurance, Regulatory Affairs
• Research & Development
• Operations Managers, Manufacturing Managers
• Engineers and Service Providers

• Participants attending this course are preferred to have prior knowledge of medical devices and quality management system.

• Get an introduction to Medical Device Single Audit Program (MDSAP) and its regulatory framework
  
• Familiarise with the scope and purpose of MDSAP
• Review the MDSAP audit model and its alignment with international standards
• Understand the key elements of QMS: Risk Management, Design Control and Production Processes
• Analyse regulatory affairs, compliance requirements, and audit techniques that are critical for ensuring the quality and safety of medical devices.

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

• Exam duration: 60 minutes
• Passing criteria: 70%

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 South Asia’s successful completion certificate, which indicates that the candidate has passed the examination.

1. When can I get the certificate?
Certificate will be issued within 21 working days from the examination date.

2. When can I get the training material and invite?
One day before the commencement of the training program.

3. How do I pay the fees for training and examination?
Online mode.

4. What are the benefits of the Internal Auditing Training on Medical Device Single Audit Program (MDSAP)?

• Get an introduction to Medical Device Single Audit Program (MDSAP) and its Regulatory Framework
• Familiarise with the scope and purpose of MDSAP
• Review the MDSAP audit model and its alignment with international standards
• Understand the key elements of QMS: Risk Management, Design Control and Production Processes
• Analyse regulatory affairs, compliance requirements, and audit techniques that are critical for ensuring the quality and safety of medical devices
• Gain the ability to navigate the complexities of MDSAP
• Provide assistance in achieving and maintaining compliance, reduce regulatory risks, and compete effectively in the global medical devices market

5. Is there any refund policy for the paid fees?
Please refer to Cancellation and Refund policy page.