Setting the record straight…. what do some terms and phrases mean within the ISO13485 Standard

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. …

Setting the record straight…. what do some terms and phrases mean within the ISO13485 Standard Read More »