EU MDR Strategies: How to Achieve a Market Advantage While Streamlining Regulatory Compliance, New Webinar Hosted by Xtalks Sponsored by Kalypso

TORONTO, October 25, 2018 (Newswire.com) - The European medical device industry is undergoing a transformation as the new European Medical Device Regulation is set to replace Medical Device Directives (93/42/EEC) and Active Implantable Medical Device Directive (90/385/EEC) by 2020. The European Union Medical Device Regulation (EU MDR), which was published in the Official Journal of the European Union on May 5, 2017, is aimed at restoring confidence in the European regulatory system after widespread safety issues and corrupt Notified Body engagements. These regulations are directed to increase post-market surveillance, expand the use of Unique Device Identifiers and provide better oversight of Notified Bodies.

Those organizations that are non-compliant will be unable to participate in the EU market until they are certified, which was recently estimated to be a market worth €14.11 billion across EU’s 10 largest economies, plus Switzerland.

Sandra K. Rodriguez, Market Analyst at Axendia, and David Wolf, Senior Consultant and Certified Auditor at Kalypso, will discuss key strategies on how to achieve EU MDR compliance, in a staged approach, become an EU MDR pioneer and take market share from competitors.

Join this informative and interactive presentation on Friday, Nov. 9, 2018, at 11 a.m. EST (4 p.m. GMT/UK).

For more information about this complimentary event, visit EU MDR Strategies: How to Achieve a Market Advantage While Streamlining Regulatory Compliance.

ABOUT Kalypso

Kalypso has a long history of supporting medical device companies and they improve innovation performance that delivers sustained results and bottom-line growth.

We partner with our clients to implement innovation capabilities throughout the development lifecycle in order to deliver commercially successful devices, products and services that meet today’s evolving healthcare needs. We do this by developing and operationalizing strategies, organizational structure and processes; aligning them with regulatory requirements; and enabling with technology.

Learn more at www.kalypso.com/medtech.

ABOUT XTALKS

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.

To learn more about Xtalks, visit http://xtalks.com.

For information about hosting a webinar, visit http://xtalks.com/why-host-a-webinar/.

Contact:

Nima Rajan​
Tel: +1 (416) 977-6555 ext 352
​Email: [email protected]

Source: Xtalks