SOURCE: Xtalks

Xtalks Webinars

January 26, 2017 07:30 ET

Medical Device Regulation: Finding Your Path to Success, a New Webinar Presented by Premier Research

TORONTO, ON--(Marketwired - January 26, 2017) - The live broadcast taking place on Tuesday, February 14, 2017 at 11:00am EST (4pm GMT/UK) will explore the medical device development process, the changing regulatory environment, and the device approval pathways to help sponsors optimize the likelihood of regulatory and commercial success.

Successfully navigating the medical device regulatory landscape requires a well-defined and understood approach and knowledge of best practices specific to the device field. While device and drug development follow the same basic steps, there are key differences in regulations, approval pathways, and clinical investigations required for medical devices in the United States and European Union.

There are also clear definitions in the clinical investigations needed to support marketing approval, in part due to the durable nature of devices, which may be implanted in a patient's body for extended periods. Understanding where the evolution of devices and drugs diverge is critical to ensuring proper planning along the development continuum, from discovery to post-market surveillance.

  • Key distinctions between devices and drugs
  • The regulatory landscape in the U.S. and EU
  • The device development process
    • Looking at key stages: discovery through post-market surveillance
  • Classification of medical devices
    • Important definitions
    • Defining risks and classification differences between the U.S. and EU
  • Applying ISO
    • Pre-risk analysis questionnaire
  • Quality by design
  • Approval pathways

Join Joanne Emmett, Vice President, Medical Device & Diagnostics and Lisa Pitt, Vice President, Global Regulatory Affairs, both from Premier Research for an informative session. For details or to register for this complimentary event visit:

About Premier Research

Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs, with a special focus on addressing unmet needs in areas such as analgesia, CNS, rare diseases, medical device and diagnostics, oncology, and pediatric research. Premier Research operates in 84 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.

To learn more about Premier Research visit:

About Xtalks

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech 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:

For information about hosting a webinar visit:

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