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Northeastern University - Toronto: ALERT Lecture Series feat. Synaptive Med...

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First Canadian Place

100 King Street West

Suite 4620

Toronto, ON M5X 1E2

Canada

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Join us for the first in a lunchtime lecture series presenting topics of interest in the field of Regulatory Affairs.

The first speaker in this series will be Maham Ansari of Synaptive Medical—a medical device manufacturer located in downtown Toronto. Her presentation is entitled “MDSAP: A New Paradigm in Medical Device Quality Systems Auditing”.

About MDSAP

The Medical Device Single Audit Program (MDSAP) is an international initiative developed by the International Medical Device Regulators Forum (IMDRF) at its inaugural meeting in 2012. The program allows an Auditing Organization (AO) to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. The program remained in a pilot phase until December 2016 and has now been qualified for its viability. While the program does not introduce new regulations, it does introduce a new approach in auditing that medical device manufactures are struggling to adopt.

The first half of this lecture shall provide an overview of the program, its connection to ISO 13485: 2016, and specific nuances related to Health Canada’s requirements as the only regulatory authority yet to make compliance to MDSAP mandatory.

The next half of the lecture shall cover some tips on how manufacturers can prepare for this audit and a real-life success story of a manufacturer that has undergone the inspection and the lessons learned from it. By the end of this lecture, attendees should be able to define an MDSAP audit, understand its benefits and challenges and develop an appreciation for what companies have to do to successfully pass the inspection.

About the Speaker
Maham Ansari, MS RAC currently serves as a Director of Regulatory Affairs at Synaptive Medical, a leading Canadian medical device manufacturer specializing in the design of imaging diagnostic applications and surgical robotics in neurosurgery. She has a successful track record in developing global regulatory strategies and securing regulatory approvals on high risk products on a global scale. She has worked both in North America and Europe within the in vitro diagnostics and medical device industry taking roles of increasing responsibility.

Maham has also hosted numerous Quality audits through her career, has developed and implemented Quality Systems from scratch, and led companies through successful FDA and Notified Body inspections. She recently led her company through a successful MDSAP audit. Maham has an undergraduate degree in Chemical Engineering from the University of Toronto and a Master’s in Biotechnology & Regulatory Affairs from the Johns Hopkins University. She also maintains a Regulatory Affairs Certification through the Regulatory Affairs Professionals Society.

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Date and Time

Location

First Canadian Place

100 King Street West

Suite 4620

Toronto, ON M5X 1E2

Canada

View Map

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