CARAQA class on MDSAP Introduction
Speaker: Koushik Ayalasomayajula

Objectives:

- Creating awareness by understanding principles and approach of MDSAP program ​
- Explain the structure and scope of the Medical Device Single Audit Program (MDSAP)​
- Understand the main requirements of the MDSAP audit processes and their interrelationships ​
- Understand legal framework for medical devices in MDSAP jurisdictions​

Agenda:
- Introduction to MDSAP​
- Legal framework MDSAP jurisdictions​
- Audit sequence​
- Post audit activities​
- Preparatory steps to be taken by manufacturer​