Clinical Trial Design for Medical Devices

Clinical studies are an integral part of the approval process for medical devices. While some devices may be approved with little or no clinical data, for others, manufacturers need to demonstrate, with safety and effectiveness data in the target population, that the product is safe for human use.

This course offers an overview of the regulatory process for medical device applications, including medical device clinical trial design and implementation. Throughout, examples and case studies will help participants apply the concepts being covered.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.