About MDSAP
KARA & Associates: Your Subject Expert in the MDSAP Regulatory Puzzle
The Medical Device Single Audit Program (MDSAP) is a global initiative designed to harmonize regulatory efforts around the world. But despite looming deadlines, comparatively few medical device companies have a meaningful understanding of the advantages (and disadvantages) of pursuing MDSAP certification and how to prepare accordingly.
KARA & Associates consultants are subject matter experts in MDSAP requirements. We are actively involved working in helping companies comply with MDSAP requirements. Our involvement can be QMS development, training and internal auditing to MDSAP requirements.
OUR TRAINING PROGRAMS INCLUDE
General Awareness training
Executive Management training
Auditor Training
In-Depth MDSAP and regulatory training
KARA’S TWO-DAY TRAINING SESSIONS INCLUDE:
- Concepts and Principles of MDSAP
- The basics of the MDSAP
- How the new grading system works
- NCR reporting
- Audit Process and Sequence
- How to prepare for success before auditors arrive
The seminar focuses on:
Understanding the Medical Device Single Audit Program companion document, the scope of the program, how to apply, the Authorized Organizations, the rating system developed and what you can expect when signing onto the program.
This session will cover how such audits are organized, what to expect during a MDSAP audit, how does this differ from a typical certified body audit, along with document movement and timeline expectations in receiving the facility’s certificate.
The key Regulatory Requirements for Medical Devices will also be covered for the participating MDSAP Countries of: U.S., Canada, Brazil, Australia and Japan.
Learning Objectives:
- The Medical Device Single Audit Program (MDSAP)
- Review of each Chapter and tasks, discuss regulatory implications
- Licensing Pathways
- License Holder Responsibilities
- Country Specific Cultural Considerations and Challenges
- Adverse Event Reporting