Day

June 29, 2005
Recipient:Con-Med Corp.Product: Irrigation pumps, hand pieces and surgical drills Date: 6/29/05 Software flags were added to rechargeable batteries after complaints were received referencing the battery’s depletion during surgery. No verification or validation of this corrective action was conducted. FDA District: Florida District Office
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ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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