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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an On-demand
recording from February 2020.
All medical device manufacturers who want their
documentation, labeling or quality processes to remain compliant need to
understand the language and translation requirements and implications of the
new EU MDR. The overwhelming majority of medical device manufacturers will not
be compliant by the May 26, 2020 enforcement deadline. In this webcast, you'll
hear from leading medical device regulatory experts who will provide insights
about how the current language requirements will change with the upcoming
enforcement date. They will outline essential information and considerations
for device manufacturers across the EU and explain everything you need to do to
remain compliant. The upcoming EU Medical Device Regulation (MDR) is the most
sweeping change to the EU medical device landscape in two decades; make sure
your organization is prepared.
Intermediate: Content is designed based upon the
assumption that individuals have basic knowledge of the topic(s) and/or
demonstrated competence related to the topic(s). Higher-level concepts are
introduced during lectures; exercises requiring synthesis and/or application of
concepts are incorporated into the activity.
This webcast will cover:
The major changes coming with the EU MDR with
important dates and timelines
The new EU MDR’s specific requirements for
language and translation, including the challenges manufacturers will face and
what you need to do to prepare your organization
How the MDR will affect your existing
multilingual content and QMS
Who Should Attend?
Mindy McCann, vice president of regulatory
compliance, Qserve Group
Mindy McCann, vice president of regulatory compliance,
brings decades of experience in medical device international regulatory affairs
and quality management to her role at Qserve. Before joining the medical device
consulting company, Mindy worked as a development engineer, notified body
auditor and technical file reviewer, global certification manager, and
regulatory and business executive for a wide range businesses. She applies a
practical approach to developing and implementing regulatory strategies and
quality procedures; auditing; and writing and reviewing clinical evaluation
reports, technical documentation, and clinical investigation protocols and
Mindy has a degree in Biomedical Engineering from Carnegie
Mellon University and a Masters in Chemical Engineering from the University of
Delaware. Her broad and multi-faceted experience, enthusiasm for regulatory
compliance and communication skills make her an effective project manager and
Bob Russell, president, RJR Consulting
As president and CEO of RJR Consulting Inc., Bob Russell
assists the pharmaceutical, medical device and biotech industries in
understanding and complying with international regulations affecting
compliance, new product development, manufacturing and quality assurance. RJR
consulting has offices in Columbus, Ohio, Brussels, Belgium and Buenos Aires,
Argentina and over the last 19 years, Mr. Russell has developed a network of
regulatory affiliate offices to meet company’s global business expansion plans
in over 95 countries. He has practical hands-on experience assisting clients in
preparation and readiness for compliance to the EU MDR and EU IVDR. Prior to
founding RJR Consulting in 2001, Mr. Russell spent 28 years in the pharmaceutical
and medical device industry with two Fortune 150 firms working in CMC, Global
Business Development and Regulatory Affairs.