- 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
- Medical Device Innovation Handbook from University of Minnesota
- 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
- The True Cost of Medical Device Product Development
- 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.