Medical Device Single Audit Program Preparation

Fremont (United States), 6 April 2018


Key deadlines
Conference starts:
2018-04-06
Website

Visit the conference website

Conference Description

Overview:
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

Who Will Benefit:
Corporate Management (Presidents, CEOs, COOs)
Quality Management (Vice Presidents, Directors, Managers)
Regulatory Management (Vice Presidents, Directors, Managers)
Sales & Marketing Management (Vice Presidents, Directors, Managers)

Speaker Profile:
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

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Conference creator: compliance4all

Actions menu

Conference Location

image placeholder

18004479407 161 Mission Falls Lane, Suite 216,,
Fremont 94539 (United States)

Tags for this conference

Comments

No comments yet!

You must register or sign in to post a comment.