The Medical Devices Single Audit Program (MDSAP) was created by the International Medical Device Regulators Forum (IMDRF) to allow manufacturers to meet the quality management system (QMS) for participating countries with a single QMS audit.
The MDSAP gives manufacturers the opportunity to meet Quality System requirements for major markets including the USA, Canada, Australia, Japan and Brazil, all in a single audit!
Out of these countries, Canada has already announced it will replace its CMDCAS program with the MDSAP on January 1, 2019. If you have sales in Canada, it’s critical you understand the effect on your business.
As an Auditing Organization, UL can provide MDSAP registrations for your medical device manufacturing sites. Contact us to receive a quote for MDSAP services.
Date: Wednesday, August 16th, 2017
Time: 08:00 AM Pacific / 11:00 AM Eastern (GMT – 4)
Duration: 30 Minutes
Where: Live online
Register below to attend our 30-minute live webinar, including Q&A to learn more about the MDSAP program, and hear from one of UL’s experienced lead auditors on the major program requirements.
In this webinar we will cover:
- MDSAP Implementation – key dates
- MDSAP Process Overview - from quote to completion
- Country Specific requirements
- Grading and reporting findings
Who Should attend:
- Medical Device manufacturers
- Regulatory Affairs
- Quality Assurance
- Business owners
Deborah Stubbs, Staff Engineer, Lead Auditor
Ms. Stubbs is a Lead Auditor for Medical Management and Risk Management and also a Regional Lead Reviewer for Regulatory Medical Management.
Ms. Stubbs has worked with Medical Devices at UL for 19 years and has a high level of expertise in the safety standards for Medical Equipment and Programmable Electrical Medical Systems (PEMS). These include IEC 60601-1, it’s associated Collaterals and Particular Standards, IEC 62304 and IEC 61010. Deborah has performed product safety assessments against these requirements for 19 years.
She has also worked with 510k Reviews for Products in the US and is also a first pass Assessor of Technical Files for the Notified Body with an expertise in Software and PEMS. She is a Lead Auditor for ISO 13485 Quality Systems and also ISO 14971 Risk Management Systems.
Deborah obtained her Bachelor of Science degree in Electrical Engineering from University of the Pacific, Stockton California.