|Companies developed risk management systems |
for their devices using the ISO standardized process.
Medical devices have been developed with some requirements for product safety since the implementation of the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act. Initially FDA required manufacturers to submit information related to safety as part of the 510(k) premarket notification process, providing comparative data on predicate devices versus the device under consideration. In the more rigorous Premarket Approval (PMA) process, more detailed safety information on the device under consideration has been required. Additionally, in a guidance document published in 1991, the FDA required a “hazard analysis” in all premarket submissions for devices containing software.
As far back as 1986, risk analysis was required to receive the CE Mark in Europe. In 1994, with the implementation of Europe’s Medical Device Directive under the Essential Requirements section of the law, product safety information was required and a European standard was developed to conduct risk analysis for devices under consideration, EN 1441. That standard began a push to develop an international standard for risk, which eventually became ISO 14971 on risk management, released in 2000, and revised in 2007.