This item addresses Product Realization: Design & Development (ISO 13485 §7.3), Product Realization (ISO 13485 §7.5.1) and Installation (ISO §7.5.4)
Please download : CPDS global QMS : Design & development and installation
‘Product Realization, Design & Development and Installation’ Refer to / taken from Ensuring Compliance: Navigating the EU MDR for Drug-Device Combination Products
CPDS QMSR update of 2022 EFPIA EU US comparison. The Global Pharma combination product QMS is within reach.