'How an EQMS can make the transition to MDR seamless'

04 December 2017

Webinar | December 14, 2017

Featuring MasterControl

The Medical Device Regulation (MDR) is now a reality, having been published for final review. Medical device manufacturers, suppliers and other service providers will be impacted by the regulation. Companies will need to assess their current operations documents and standard operating procedures and develop a plan for complying with the new MDR requirements.

While documents, training and supplier management will become more critical, postmarket surveillance programs will be even more of a concern. This webinar will examine some of the more pervasive changes, as well as the new chapters and other additions. Attendees will also learn how his/her company will need to change or update its current quality systems and processes to comply with the new requirements.

Speakers featuring Alex Butler, Manager of Medical Device Solutions, MasterControl

Alex Butler has a deep understanding of the FDA’s submission process and audit procedures, having navigated several medical devices successfully through market. Butler has written several articles (see “10 Things I Wish I’d Known Before Writing my FDA Response Letter”) and has been interviewed by the media extensively.

He currently serves on BioUtah’s Regulatory, Compliance and Quality Committee. Alex is the lead Product Marketing Manager for MasterControl Registrations, and he’s responsible for developing and/or improving other solutions, including MasterControl Complaints, Bill of Materials (BOM), Projects, Risk, and Supplier Management.

Prior to joining MasterControl, Butler worked as a product development manager for Opal Orthodontics, a division of Ultradent Products Inc., where he helped launch several Class II medical devices, including the Opal Espirit™ Class II Corrector.

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