The Medical Device Single Audit Program (MDSAP) is an international initiative spearheaded by the International Medical Device Regulatory Forum (IMDRF) to develop a standardized global approach to auditing and inspecting of medical device manufacturers that will be accepted by multiple regulators to address QMS/GMP requirements.
After a multi-year pilot program ended in December 2016, the formal program began implementation at the beginning of 2017.
Although the program has seen relatively low participation to date, the promise to help reduce compliance cost for device makers by eliminating the need for multiple quality system audits and inspections means there is much to be gained by industry from a successful implementation the program.
In our upcoming free 60 minute webinar lead by Kyle Rose, President of Rook Quality Systems, you will be given a thorough overview of the program to understand its many potential benefits to manufacturers, and how your device company can begin preparing for implementation now.
SPECIFICALLY YOU WILL LEARN:
Understand the goals and benefits of the MDSAP program
What are the main differences between MDSAP and standard auditing
How to benchmark your QMS against the MDSAP
How the new non-conformance grading system works
How to prepare your company for a successful MDSAP implementation
*Note: Limited live seats available.
Medical Device Executives
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management
This webinar is being lead by Kyle Rose, a medical device expert specializing in development of efficient Quality Systems for small and startup medical device companies.
As President of Rook Quality Systems Mr. Rose works as a the contract Quality Manager for multiple medical device companies overseeing overall quality strategy and ensuring compliance through documentation and auditing services.
Mr. Rose is a certified quality auditor (CQA) and has regulatory and submission experience for a variety of markets including FDA, CE Mark, Health Canada, and CFDA. Mr. Rose encourages the simplification of Quality Systems to reduce the quality burden and improve compliance through training and efficient QMS design.
Greenlight Guru produces beautifully simple Quality Management Software that helps medical device companies bring safer devices to market faster while reducing risk and ensuring compliance. Visit our home page to learn more.
Rook Quality Systems provides specialized and custom consulting services for all classes of medical devices. We work with you to outline your quality and business goals to develop innovative and efficient practices that improve compliance and profit. To see a full list of the services Rook offers you can go here.