Medical Device Regulation: Finding Your Path to Success

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

  o  Looking at key stages: discovery through post-market surveillance

• Classification of medical devices

  o  Important definitions

  o  Defining risks and classification differences between the U.S. and EU

• Applying ISO

  o  Pre-risk analysis questionnaire

• Quality by design
• Approval pathways