Risk Management

Does a Human Factors/Usability Engineering (HFE) validation study need to be completed for your medical device?  If your Risk Management process is not integrated with HFE, how and when to integrate it into the product development process can be important...

For medical devices, ISO (International Organization for Standardization) is one of the most significant organizations. ISO issues international standards. Often, national or regional standards organizations adopt the international standards and change their designations. The current international standard for medical device...