Given the recast of the European Medical Device Directive and the recent changes to the FDA’s 510(k), the regulatory climate in the medical device industry is more volatile than ever. Medical Device manufacturers are concerned with staying up-to-date with these regulations, accelerating time to market, reducing cost and improving profit margins. Moreover, expanding into different markets within and outside Europe poses new issues – can you risk not being on top of the latest changes?
Opal Events’ Medical Devices Summit Europe will address these topics and help you prepare strategies to meet current and to anticipate incoming challenges.
Join us for two days of panels, presentations and networking opportunities with high-level individuals from across the industry as we discuss the hottest issues, including:
- Regulatory updates and changes to the 510(k) and the EU Directive
- Strategies for successful submissions, maintaining compliance and improving quality
- Spotlight presentations on foreign markets, including:
- Expanding into foreign markets
- Integrating best practices into your clinical trials
- How reimbursement varies in different markets
- Usability and device design
- Best practices for international recalls
For further information please visit: http://www.opalevents.org/trk/mdseuc1205.html