Sponsored Webcast: EU MDR Prep: Translation Requirements That Will Make or Break Your Devices In Eur

When:  Feb 12, 2020 from 12:00 PM to 1:00 PM (ET)


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.

 

Learning Level

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.

 

Learning Objectives

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?

·         Regulatory Professionals

·         Quality Professionals

·         Technical Writers

·         Labeling Specialists

 

Speakers


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 applications.

 

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 engaging trainer.

 


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.

 

Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.