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Wednesday, April 11 • 8:30am - 10:00am
Session O - Roundtables Track

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O-1   Supporting the Medical Device Single Audit Program (MDSAP): The Role of the CRO

A global approach to auditing and monitoring the manufacturing of medical devices has been developed from an international coalition between the United States, Australia, Brazil, Canada and Japan. This international consortium, Medical Device Single Audit Program (MDSAP) became fully operational in 2017. Starting the 1st of January 2019, MDSAP will be the only certification accepted by Health Canada. The Canadian MDSAP transition period corresponds closely with the transition period for the revision of ISO 13485. With MDSAPS full implementation on the horizon, time is flying by.
MDSAP allows medical device manufacturers the opportunity to achieve and maintain regulatory compliance, including the consortium countries, with a single audit certification. The MDSAP audit report has bene accepted as a substitute for routine Agency inspections. The audit, based on ISO 13485 and 14155, requires a preparation period to ensure compliance to the MDSAP guidance.
Due to the nature of our CRO business, we have diverse clientele and offer practical and customized services with an expertise in medical device clinical research. As international regulations evolve, our team is undergoing a global effort to establish best practices to accommodate and preemptively maintain compliance.  Key factors to consider for proactive implementation:
·        Contracts designed in compliance with the guide prior to certification
·        3rd Party Auditing Organizations scheduling, expect delays and forced prioritization
·        Effects of BREXIT, have a contingency plan
·        EU MDR/IVDR timeline early 2020, extends the QMS adaption timelines
·        Re-designation of Notified Bodies, anticipate more demand of and from Notified Bodies
·        Post-audit time frames, e.g., nonconformities etc.

Medical Device

Level of Content:

avatar for Bethany Davis

Bethany Davis

Bethany has over twelve (12) years of experience in the pharmaceutical and research industry. Before joining Clinlogix, Bethany’s experience includes McNeil Consumer Healthcare, Dr. Reddy’s Laboratories and The Commonwealth Medical College.  Bethany has designed and implemented... Read More →

Wednesday April 11, 2018 8:30am - 10:00am PDT
Platinum 9&10

Attendees (6)