ISO 13485 Design Changes: Device Design Change Control
Design changes in medical devices could be modifications made to the design, materials, functionality, or intended use of the device. Moreover, changes in medical device design, manufacturing processes, or regulatory requirements are inevitable in the industry. Hence,...
Revised Risk-Based Classification List for Cardiovascular & Neurological Medical Devices
Central Drugs Standard Control Organisation (CDSCO) is the apex regulatory body for medical devices, drugs, and cosmetics in India. The CDSCO works under the guidance of Medical Devices Rules (MDR), 2017. The Drug Controller General of India (DCGI) is the governing...
Medical Device Transport Validation: Everything You Need to Know
Transport validation is performed to demonstrate the device will remain safe during transportation. Additionally, it ensures the device will perform as intended when they reach the end user. Hence, performing transport validation is a mandatory requirement for most...
Process Validation for Medical Devices: Your Detailed Guide
Process validation for medical devices is performed to demonstrate the finished product will consistently meet quality specifications and user requirements. Hence, regulatory authorities require manufacturers to perform process validation to demonstrate their finished...