An opportunity came up to help provide clarity on some of the specifics within ISO13485 during a regional conference recently. These slides provide explanation to some of the terms and phrases within the Standard. Hope it helps the auditee and the auditor of any medical device company, or certification company, understand the ISO13485 Standard better.
Also included are some of the new definitions that would be included in the proposed revision, and they’ll be updated as information arrives. Feel free to post your questions and hope we can help you with them!