Global QMS

One Global Quality Management System for Combination Products

manufacturers, led by individuals with executive responsibilities, to embrace a culture of quality as a key component in ensuring the manufacture of safe and effective combination products

1) CPDS Global QMS : General General / Definitions’ Refer to / taken from Integrated Quality Management System Framework

2) CPDS Global QMS : Management ‘Management responsibility’ Refer to / taken from Ensuring Compliance: Navigating the EU MDR for Drug-Device Combination Products ‘Management commitment’ Refer to / taken from Ensuring Compliance: Navigating the EU MDR for Drug-Device Combination Products

3) CPDA global QMS : Resource management and Purchasing controls Resource management and Purchasing control, Refer to / taken from Ensuring Compliance: Navigating the EU MDR for Drug-Device Combination Products

4) CPDS global QMS : Corrective and preventive action ‘CAPA’ Refer to / taken from Ensuring Compliance: Navigating the EU MDR for Drug-Device Combination Products

5) CPDS global QMS : Product realization, design and development ‘Product Realization, Design & Development and Installation’ Refer to / taken from Ensuring Compliance: Navigating the EU MDR for Drug-Device Combination Products

6) CPDS global QMS : Risk management ‘Risk Management’ Refer to / taken from Ensuring Compliance: Navigating the EU MDR for Drug-Device Combination Products

7) CPDS global QMS : Measurement improvement and analysis ‘Measurement, Analysis & Improvement’ Refer to / taken from Ensuring Compliance: Navigating the EU MDR for Drug-Device Combination Products

8) CPDS global QMS : Post market surveillance, Vigilance ‘Post market surveillance, Vigilance and Handling communication with competent authorities’ Refer to / taken from Ensuring Compliance: Navigating the EU MDR for Drug-Device Combination Products