SOURCE: Xtalks

Xtalks Webinars

July 27, 2017 07:30 ET

Medical Devices: Reviewing Regulatory Changes in the US and EU, New Webinar Hosted by Xtalks

In the United States, MDUFA and other regulations updated in 2017, have an immediate impact on how medical device manufacturers are developing and marketing their products; There are steps medical device manufacturers can take to comply with all regulations and help ensure successful clinical trial execution

TORONTO, ON--(Marketwired - July 27, 2017) - The live broadcast takes place on Thursday, August 24, 2017 featuring guest speakers from INC Research including Angela Stokes, Senior Director of Regulatory Consulting, and Eric Distad, Executive Director of Clinical Development, Medical Device and Diagnostics.

The Medical Device Regulation (MDR) and In-vitro Medical Device Regulation (IVDR) came into effect in Q2 of 2017. The transition period will be 3 years for the MDR and five years for the IVDR, meaning that the dates of application will be Q2 2020 and Q2 2022 respectively. We have 3 (or 5) years, so we don't have to do anything immediately right? Wrong! There are some pretty major changes so it is essential that medical device manufacturers get management engaged in the process now so that money and resources can be available to support and implement the new regulations.

Angela Stokes will discuss the funding, people and steps to be taken now to ensure the major aspects of the new regulations are known, and plans are put in place to deal with modifications in classification, format of technical files, conformity assessment routes and other changes to ensure an uninterrupted supply of medical devices in the marketplace. Eric Distad will share his extensive experience in navigating US and global regulations on medical device development and offer insight into best practices for medical device clinical development in this era of increased regulatory review.

For more information or to register for this complimentary event visit: Medical Devices: Reviewing Regulatory Changes in the US and EU

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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