Medical Device Development and Market Strategy: Europe or US First? Or Both? Upcoming Webinar Hosted by Xtalks
TORONTO, Oct. 23, 2023 /PRNewswire-PRWeb/ -- Historically, medical device developers often opted to bring new products to market in the EU first, as obtaining a CE mark was perceived to be faster, less expensive and more predictable than getting US FDA clearance or approval. With the introduction of the EU's Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), the paradigm has shifted, and an increasing number of medical device companies are prioritizing the US market. However, the decision of where to launch first must be guided by more than just regulatory requirements.
In an evolving global regulatory landscape where technology is advancing rapidly, medical device developers need to adopt a holistic approach to aligning their product development and go-to-market strategies to optimize the likelihood of regulatory and commercial success. In this webinar, the featured speakers will explore key considerations for prioritizing markets and optimizing the path to product launch.
Join this webinar to gain insights into:
- The comparison of the regulatory landscapes for medical devices and IVDs in the EU and US
- Risk classification of medical devices and IVDs in the EU and US and its impact on product development and associated requirements
- How to develop a rigorous clinical and regulatory plan to support your priority market
- Guidance on aligning product development and go-to-market strategies
- Real-world examples that bring these key considerations to life
Join Matthew Nowland, Vice President, Regulatory Affairs, MedTech, Premier Consulting; and Michael Edwards, Senior Director, Regulatory Affairs, MedTech, Premier Consulting, for the live webinar on Friday, November 3, 2023, at 11am EDT (4pm CET/EU-Central).
For more information, or to register for this event, visit Medical Device Development and Market Strategy: Europe or US First? Or Both?
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/
Media Contact
Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, vkovacevic@xtalks.com
SOURCE Xtalks
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