By understanding this evolving regulatory landscape, device manufacturers across the globe can better position their products to adapt to these changes in support of their device development programs.
TORONTO (PRWEB) April 23, 2020
Medical devices play an increasingly critical role in the health and quality of life for millions of people worldwide. While clinical trials for medical devices have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct from that of drugs – and there are critical differences in the way the device trials are designed and executed.
In a live webinar taking place on Monday, May 11, 2020 at 3pm KST (Korea), Premier Research’s Nach Davé, Vice President, Development Strategy, and Marlis Sarkany, Senior Medical Director, draw on their extensive experience in both medical device and clinical product development to share what manufacturers need to know. The pair will explore the latest US and European medical device regulatory pathways, agency expectations and other critical best practices.
To reflect the substantial technological and scientific advances made by the medical device sector and to respond to the need for regulations that would significantly tighten the controls around medical devices, the European Commission published the EU Medical Devices Regulation (MDR) on May 5, 2017.
These regulations seek to set the standard for medical device regulation globally and impact the entire product development cycle, from concept to clinical trial conduct and post-marketing surveillance. Manufacturers will need to conduct more rigorous clinical investigations than ever on both safety and effectiveness to support their claims both in Europe and in the US.
By understanding this evolving regulatory landscape, device manufacturers across the globe can better position their products to adapt to these changes in support of their device development programs. Register for the webinar today for an in-depth look at the changes being proposed and the requirements that will need to be met by device manufacturers willing to do business in Europe and beyond.
For more information or to register for this event, visit Asia-Pacific – Taking Device Clinical Development to the US & Europe: Understanding the Changes & Leveraging the Opportunity.
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device 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.