According to the FDA, a medical device is “any instrument, machine, contrivance, implant, in vitro reagent that’s intended to treat, cure, prevent, mitigate, or diagnose disease in man.” The FDA imposes strict requirements for the engineering development, testing, and documentation of every medical device. This regulatory burden increases with the class of the device.
- Class I devices present minimal potential for harm to the user (e.g., elastic bandages).
- Class II devices represent some danger in the event of a failure (e.g., a powered wheelchair).
- Class III devices usually sustain or support life (e.g., a pacemaker).
Medical devices must be developed within the framework of a Quality Plan such as ISO-13485 or 21 CFR 820 (QSR).
Porticos has assisted some of the largest and best-known medical device companies in the world to develop, troubleshoot, and perfect medical devices. We are proud to have provided engineering assistance to Teleflex, Becton Dickinson, Intuitive Surgical, and many others.