Utah Chapter: MDSAP: What Does It Mean for Medical Device Manufacturers?

When:  Sep 5, 2019 from 11:30 AM to 1:30 PM (ET)

Member: $30
Nonmember: $50

The Medical Device Single Audit Program (MDSAP) is designed to globally harmonize the medical device industry to one quality management program. Join RAPS Utah Chapter and Intertek’s Alexander Crosby, as he discusses some of the common issues and expectations with MDSAP. Crosby will be touching on what to expect when transitioning to the program, changes, additions and updates and how the program lays out a road map for the prospective future of quality systems management in the Medical Device industry.

Among other topics, the following will be discussed:

  • What feedback have the MDSAP RAs given to the Auditing Organizations (AOs) on the report content and on how the audits are conducted?
  • How does the MDSAP program calibrate AOs including their application of the MDSAP audit model and finding grading system?
  • What is means to dispute a score or finding?
  • What is the status of other countries joining or accepting the MDSAP program?

NOTE: Intertek does not speak for the MDSAP program or for all Auditing Organizations (AOs) but will address questions in general, with the caveat that some of this information is not known.

This workshop, hosted by MasterControl, is brought to you by the RAPS Utah chapter and is intended to promote knowledge sharing and networking among professionals in the regulatory and related industry. Breakfast will be provided to all attendees and RAC holders may claim three RAC recertification credits

Featured Speaker:
Alexander Crosby, Americas medical program manager, Intertek

Location

6350 S 3000 E
Old Mill III Building
Cottonwood Heights, UT 84121-5952