Standards perform a key role in the conformity assessment process; however, utilizing
existing standards for recognition of medical device CABs performing regulatory
reviews presents challenges. Regulatory Authorities have identified shortcomings
such as requirements being too generic and focused on commercial entities for
commercial purposes. While there is utility of the requirements outlined in the
standards, additional requirements need to be added to ensure that they meet the
requirements of Regulatory Authorities and are appropriate for the regulated medical
device industry…
