Today’s tale is one of inadvertent mishandling of internal audit findings —a grim reminder of what befalls those who ignore the warnings etched into the very bones of Clause 8.2.4 of ISO / EN ISO 13485:2016 which states that, "The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.

🎙 Welcome back to another insightful episode of Tales from the Audit Crypt ! Today, we unravel a critical but often undermanaged aspect...

In the intricate tapestry of the medical device industry, regulatory audits stand as the gatekeepers of compliance, ensuring that...