Training duration: 3 Days
Course overview
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 the regulatory framework
- Purpose and scope of MDSAP
- Quality Management System (QMS) requirements
- Overview of the MDSAP audit model and its alignment with international standards
Day 2
- Design and development controls
- Production and service controls
- Purchasing activities
- Device marketing authorization and facility registration
- Country-specific MDSAP requirements
- Integration of MDSAP with individual national regulations
Day 3
- In-depth understanding of MDSAP QMS requirements
- Key QMS elements: risk management, design control, production processes
- Preparation for QMS audits and assessments
- Audit reporting and documentation best practices
- Assignments, group discussions, and exam preparation
Who Should Attend?
- Quality Assurance and Regulatory Affairs Professionals
- Research & Development Teams
- Operations and Manufacturing Managers
- Engineers and Service Providers
Prerequisites: Participants are recommended to have prior knowledge of medical devices and quality management systems for optimal learning outcomes.
Learning & Career Benefits
- Comprehensive introduction to MDSAP and its regulatory environment
- Clear understanding of MDSAP’s purpose and scope
- Familiarity with the MDSAP audit model’s alignment with international standards
- Deep insight into critical QMS elements: risk management, design control, and production processes
- Mastery of regulatory requirements, compliance frameworks, and audit techniques crucial to medical device safety and quality
Examination & Certification
The examination is conducted online and consists of multiple-choice questions
- Duration: 60 minutes
- Passing Criteria: 60%
- Participants are evaluated throughout the course based on punctuality, engagement, and active participation
- Final exam results are generally released within four weeks
- Successful participants will be awarded the TÜV SÜD South Asia Completion Certificate, confirming their achievement
Get in touch with us to know more.
Business address
TÜV SÜD Bangladesh (Pvt.) Ltd.
Update Tower, Level- 12, 8 & 14, 01 Shahjalal Avenue, Sector-06, Uttara Model Town, Dhaka-1230, Bangladesh
Tel: +88 02 58954115, 58954120, Ext-119
Email: [email protected]
