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.
This webinar will explore the development process, the changing regulatory environment, and the device approval pathways to help sponsors optimize the likelihood of regulatory and commercial success. The speakers will discuss these topics:
- 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 and defining risks and classification differences between the U.S. and EU
- Applying ISO: Pre-risk analysis questionnaire
- Quality by design
- Approval pathways
Title: Medical Device Regulation: Finding Your Path to Success
Date: Tuesday, February 14, 2017
Time: 11am – 12pm EST (4pm GMT / 5pm CET EU-Central)
- Joanne Emmett, Vice President, Medical Device & Diagnostics, Premier Research
- Lisa Pitt, Vice President, Global Regulatory Affairs, Premier Research