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  • hruship101 started the topic Auditor's view of DHF / DHR in the forum Introduction to Design Controls 7 years, 4 months ago

    In the medical device industry, there are various audits that takes place. For example, customer audit, notified body audit from FDA or BSI, and internal audit. If you participated in an audit, briefly describe your experience, and is DHF usually reviewed? What does an auditor looks within the Device History File (DHF)?

    Lastly, briefly describe the difference between Device History File (DHF) and Device History Record (DHR).