Topic: Medical Device Single Audit Program
Presented By: Ashley Cooley
When: Tuesday 13 February, 6:30-7:00 Dinner & Networking; 7:00 Presentation
Where: NuSil Technology LLC, 1050 Cindy Lane, Carpinteria CA, 93013
Cost: Meeting Participation is free, $15 for dinner (optional)
Registration will close at 8am on Tuesday, 13 February.
MDSAP, or the Medical Device Single Audit Program, was developed by the International Medical Device Regulators Forum to assess an entire quality system and country-specific requirements in a single audit. Participation has steadily increased since the pilot phase closed in 2016: 417 manufacturer sites were enrolled as of August 2017, and 5 auditing organizations have been recognized as of December 2017 (with another 9 auditing organizations pending recognition). In this presentation, you’ll learn what MDSAP is, how these audits are conducted, and why your organization should participate in this program. (HINT: Planning to distribute medical devices in Canada in 2019?).
About the speaker:
Ashley Cooley holds a Bachelor of Science degree in Microbiology from University of California, Santa Barbara, and is a certified quality auditor through ASQ. She has been an ASQ member since 2011, and serves as the audit chair on the ASQ Channel Cities board. Over the past ten years, Ashley has held various quality-focused roles, primarily in the medical device industry. Currently, Ashley is a QA Design Assurance Specialist for a companion diagnostics company in Carpinteria, CA.
Established in 1963, the Channel Cities section 0709 includes over 170 members from aerospace, manufacturing, healthcare, and service industries.