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‘CAPA’ Refer to / taken from Ensuring Compliance: Navigating the EU MDR for Drug-Device Combination Products

This item addresses Corrective and Preventive Action (ISO 13485:2016 §8.5.2 and 8.5.3) and requirements for associated statistical analysis (ISO 13485:2016 §7.3.6, §7.3.7, §7.5.6, §8.1 and §8.4)

Please download: CPDS global QMS : CAPA system and Statistical techniques.

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CPDS global QMS : CAPA system and Statistical techniques

This item addresses Corrective and Preventive Action (ISO 13485:2016 §8.5.2 and 8.5.3) and requirements for associated statistical analysis (ISO 13485:2016 §7.3.6, §7.3.7, §7.5.6, §8.1 and §8.4)

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CPDS QMSR update of 2022 EFPIA EU US comparison.

CPDS QMSR update of 2022 EFPIA EU US comparison. The Global Pharma combination product QMS is within reach.

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