Secure US FDA 510(k) Approval for IVDs in a Hassle-free Manner
The US FDA 510(k) approval process authorizes the marketing of IVDs in the US. Through this process the Food and Drug Administration (FDA) evaluates device safety and effectiveness before releasing it in the market. Hence, compliance with US FDA...
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...