By Patrick Kinyanjui, Fischer Connectors, Inc
ISO14971 is the Application of Risk Management to Medical Devices and is recognized as the standard for applying risk management principles to the realm of medical device manufacturing. In this space, the use of electrical connectors has grown in importance – whether to advance a current device’s capabilities, or to create an entirely new device. Regardless of their end use, they have to undergo a risk assessment profile in order to stay compliant with applicable standards. This paper will help to educate designers and manufacturers of medical devices who integrate electrical connectors into their design on some recent changes made by the FDA, and the implications of the new regulations.