MDSAP Training: Understanding the Requirements of ISO 13485:2016 & International MDSAP Audit Model (2-Day)
Understanding MDSAP training course will teach students to plan, develop and implement a QMS in accordance with MDSAP and ISO 13485:2016 requirements.
Considering the ISO 13485:2016 management system requirements and various regulatory authorities’ compliance requirements around the world and the global supply chains involved, a comprehensive program is incredibly valuable. This course provides extensive practical training and hand-on exercises, which will help prepare medical device implementers to identify critical MDSAP requirements and set up a QMS to meet international regulatory requirements.
Participants of the training will learn from highly experienced instructors with decades of experience in medical device quality management systems.
Within the 2-Day MDSAP Audit Model, you'll learn to:
- Prepare and conduct a solo internal audit
- Understand the MDSAP audit model.
- Understand and interpret the ISO 13485 and MDSAP requirements.
- Apply the proper interpretation of the standard in actual audit situations.
- Understand process auditing tools
- Conduct audits that result in real improvements to the quality system
- Plan and execute the entire audit process
The course is designed for:
- Management Representatives
- ISO 13485:2016 and International MDSAP Implementation Teams
- Auditors and others who would like to learn the widely used international management systems auditing process.
- Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating jurisdictions
- Organizations expanding their market reach to jurisdictions participating in MDSAP will also benefit from this course.
Day One
- Introduction and Welcome
- Chapter 1: MDSAP Background
- Chapter 2:MDSAP Audit Structure
- Chapter 3: Quality Management System
- Exercise 1: Risk Management
- Chapter 4:MDSAP Audit Model and Tasks
Management Processes - Device Marketing Authorization and Facility
Registration - Measurement, Analysis and Improvement
- Exercise 2: Audit Scenarios
Day Two
- Chapter 4: MDSAP Audit Model and Tasks (cont’d)
- Medical Device Adverse Events & Advisory Notices Reporting
- Design and Development
- Production and Service Controls
- Purchasing
- Exercise 3: Audit Scenarios
- Understanding MDSAP Final Exam