AUDITORS’ ORATORY: how notified bodies cope with unannounced audit pressures

In this second instalment of Auditor’s Oratory, where notified bodies share their experience and advice on coping with the evolving EU medtech regulatory climate, Paul Sim* of BSI explains how unannounced audits are changing the job of notified bodies. He also discusses how notified bodies, manufacturers and suppliers are being challenged, with all parties having to adapt and conquer a learning curve. The hope is that communication will improve and that the requirements will be fine-tuned to the advantage of all players.