MDSAP (Medical Device Single Audit Program)
Live Remote Training
Description
Provides the knowledge and skills to successfully host an MDSAP audit within your organization. Content is based on the MDSAP G0002.1.0004 Companion Document and reviews the MDSAP processes with an emphasis on the associated audit tasks.
Format
Live, instructor-led remote training.
Duration
8 hours (2 x 4 hour sessions)
Technical/System Requirements for Participants
- Windows 7 – Windows 10 (Microsoft), OR
- Mac OS X 10.9 (Mavericks) – macOS Mojave 10.14
- Google Chrome or Mozilla Firefox browser required for breakout activities
- Internet connection of 1 Mbps or better (broadband recommended)
- JavaScript enabled
- Microphone and speakers if using computer audio (USB headset recommended but not required)
- Telephone if using available long-distance # for audio
- Webcam optional
Course Outline
- Introduction to MDSAP and the MDSAP Audit Sequence
- MDSAP Process: Management
- MDSAP Process: Device Marketing Authorization and Facility Registration
- MDSAP Process: Measurement, Analysis and Improvement
- MDSAP Process: Medical Device Adverse Events and Advisory Notices Reporting
- MDSAP Process: Design and Development
- MDSAP Process: Production and Service Controls
- MDSAP Process: Purchasing
- Auditing Technical Documentation
