Med Device Trials

Medical Device Clinical Trial Design, and Operations

Device Trial Regulations, Quality and Data Management

The medical device industry comes with its own set of unique challenges when it comes to clinical trials. The Medical Device Trials Track offers insight into new tools and strategies to modernize clinical trials, ensure patient safety, comply with regulatory requirements, and improve timelines and outcomes Part A: Medical Device Clinical Trial Design and Operations will address critical issues including medical device clinical trial design, patient enrollment, protocol development and optimization, and investigational site selection. Part B: Device Trial Regulations, Quality, and Data Management will provide an in depth understanding of the complex regulatory requirements and guidelines, examine clinical data strategy and use of RWD in pre- and post-market studies and offer best practices to operationalize regulatory mandates.

SCOPE of Things Podcast