- Minimally Invasive Surgery - Ali Tavakkolizadeh, MD - Presentation (Class Access Only)
- FDA & Medical Device Development ... Real World Isses - Pamela Wegraff - Presentation (Class Access Only)
- GPS for the Body - Kirby Vosburg - Presentation (Class Access Only)
- Ergonomics in Healthcare - Aaron Ross, CPE, Partners Healthcare Occupational Health - Presentation (Class Access Only)
FDA & Medical Devices
- Food and Drug Administration Medical Devices Website
- "Federal Regulatory Issues, US FDA" - Myron Spector, PhD, 21 Feb. 2013, (Class Access Only)
- Medtech Regulatory Processes & Requirements Videos - Stanford Biodesign
- NEJM - Medical Devices - Balancing Regulation and Innovation - An informed commentary on the recent FDA changes to address medical device failures - Download - (Class Access Only)
- Federal Regulatory Issues: US Food and Drug Administration Medical Device Amendments Center for Devices and Radiological Health - M. Spector, Ph.D. - Download (Class Access Only)
- Ethicon (J&J) Wound Closure Manual
- This is a database maintained by the FDA to track adverse events reports from medical devices. Studying the failures of existing devices is an excellent means of inspiring new and improved designs.
- MAUDE SAFE - User-Friendly Database Access - Developed by Nicholas Powley, an MIT Course 2 Grad, for his medical device company, this tool automatically builds reports from the MAUDE databse. You will need to create an account, but reports are free to view, there is a fee to download.
CIMIT Acknowlengments / Publication Requirements
Please acknowledge the CIMIT source of funds in all publications and presentations of research supported by CIMIT including news releases, articles, manuscripts, brochures, advertisements, still and motion pictures, speeches, and trade association proceedings.
Include a statement: "This work was supported by CIMIT under U.S. Army Medical Research Acquisition Activity Cooperative Agreement W81XWH-09-2-0001. The information contained herein does not necessarily reflect the position or policy of the Government, and no official endorsement should be inferred."
If the research involves the use of laboratory animals, the recipient must include the following statement in any publication resulting from the research: “Research was conducted in compliance with the Animal Welfare Act Regulations and other Federal statutes relating to animals and experiments involving animals and adheres to the principles set forth in the Guide for Care and Use of Laboratory Animals, National Research Council, 1996.”
(Updated 17 Aug 2011)