The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.
Why should you Attend:
Today with a single audit, it is possible for a medical device manufacturer to satisfy the quality management system requirements of Australia, Brazil, Canada, Japan and the USA! This is the benefit of the Medical Device Single Audit Program, or MDSAP. However, there are some vital considerations before embarking upon this approach to satisfying the regulators of five major markets.
Areas Covered in the Session:
Origin of MDSAP
Applicability of MDSAP
Advantages of MDSAP
Disadvantages of MDSAP
Shep Bentley is the President and Principal Consultant for Bentley Biomedical Consulting, LLC, where he is responsible for regulatory strategies leading to FDA approvals and clearances for digital medical device companies. Shep began his career in 1984 at the Hospital Corporation of America as a research technician, and worked at McGaw Labs in Irvine, responsible for GMPs until 1989, when he joined TOSHIBA America where he managed production of various digital devices.
Event Fee: One Dial-in One Attendee Price: US$150.00