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 Europewill 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

    Target Audience:

    Opal Events' Medical Devices Summit Europe has been researched and designed specifically for executives from medical device manufacturers, specifically:

    • Chief Executive Officers
    • Chief Financial Officers
    • Chief Operations Officers

    Vice Presidents, Directors, Managers, and Engineers of:

    • Compliance
    • Quality
    • Regulatory Affairs
    • Software Engineering
    • Outsourcing
    • Supplier Management
    • Research & Development
    • Product Development
    • Commercial Operations

    Testimonials From Last Year's Event:

    It is compact, concise and yet very informative and value add summit. Very well prepared and experienced speakers.
    - Varisai Mohammed, Director of Total Quality, INQPHARM EUROPE LTD

    Very nice summit. A good networking was possible during the breaks. The list of attendees was impressive.
    - Samantha Glasgow, Quality Assurance & Technical Documentation Officer, Erfa Pharm

    One of the best conferences I have attended on Medical Devices. Very educational and enjoyable. - Philip Reavey, Senior Technical Manager, Beckman Coulter Ireland Inc.

    'The relevant, coherent range of presentations combined with an eclectic mix of personalities was perfect. An essential diary entry for 2013,'
    - Jonny Dobbin, Quality Analyst, Armstrong Medical Ltd.

    Very enjoyable two days. Good mix of serious discussions and entertainment between sessions. Met lots of interesting people. Highly recommended.
    - Liam Mulloy, Managing Director, Vascular Solutions Zerusa Limited

    An engaging, well hosted conference with a good balance of subjects, well covered by knowledgeable speakers.
    - Ian Quirk, Worldwide Director of Clinical & Regulatory Affairs, Ranier Technology

    For further information can be found at www.opalevents.org/trk/mdsec1403.html.

    If you are interested in sponsorship, exhibiting, or speaking opportunities, please contact rsotomayor@opalevents.org