Medical Devices SIG

Established Aug 2010

Advances in epidemiologic methods and information technology now permits access to evidence available from the clinical trial, real-world observational studies, domestic and international registries, medical claims data and published literature.

The mission is to determine the evidence gaps and questions, datasets and approaches for conducting robust analytic studies and improve our understanding of the performance of medical devices. Methodological discussions and real world comparative effectiveness and safety studies will be one of the main areas of concentration.

We plan to host pre-conference educational sessions, hot topic sessions, debates, symposia/workshops and poster sessions at the ISPE meetings.

Goals

• Ensure the highest quality medical device epidemiologic research contributions.
• Build a research infrastructure to study performance of medical devices and augment capabilities of existing tools.
• Design and apply innovative methodological solutions to bridge RCTs and real world studies in medical devices.
• Advance regulatory science in the area of medical devices.
• Collaborate with existing and future national and international registries/other databases and surveillance systems such as those under FDA’s MDEpiNet and Sentinel Initiative.

Please visit our ISPE Community for the latest SIG news, upcoming meetings, membership, documents library, connecting with SIG members and leaders, and more. An account is needed to access the community and join it.

SIG leader(s)