Author: Matthew Ward

Does your medical device Risk Management process include Usability / Human Factors Engineering (HFE)? For many devices, the manufacturer must have a process to evaluate the Usability of a medical device as it relates to safety.  This can be accomplished by adding processes to, or integration...

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 risk management is ISO 14971:2007....