The medical device research environment is evolving swiftly in the U.S. and across the globe.
Schulman IRB’s regulatory expertise and broad therapeutic experience in device research will help you navigate the changing regulatory requirements and ensure appropriate human subject protections.
- Schulman has reviewed all categories of device studies, from Class I through Class III, across all therapeutic areas.
- The Board’s review experience includes implantable and portable devices, diagnostic tools, human factors testing and HUD/HDE studies.
- The Board can provide Significant Risk/Non-Significant Risk determinations.
- Our Board members’ medical device experience spans more than 50 combined years of industry, academia and clinical trial management.
For more information about device studies and the regulations that govern their conduct, please review our Device Resources.
Device trials often are conducted at hospitals, academic medical centers and other institutions. Schulman has worked with over 2,000 institutions and can provide thorough, efficient centralized IRB review of multicenter device studies. By using a central IRB for all sites, researchers can expect more consistent human subject protections and significantly reduced IRB turnaround times, improving overall study safety, data and timelines.
- Ready to submit a new device study to Schulman for review? Find out how to Get Started.
- Want to know about specific requirements necessary for a new device study submission? View the essentials of Submitting a Device Study.
- Need more information on medical device research regulations? Review our Device Resources.
- Wondering if your device study qualifies for expedited review? Learn about the types of device studies that may be reviewed by Schulman’s Minimal Risk Review service.
Want to know more about the Board’s experience with device studies? Contact Business Development or call 513.761.4100.