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...
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 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...
In this blog, we have discussed what is medical device packaging validation and how to perform it. Additionally, we have highlighted the need for performing packaging validation for medical devices. What is medical device packaging validation? Medical device packaging...
Orthopaedic implants are medical devices commonly used to replace or support damaged or missing bones and joints. Different types of orthopedic implants are used in the healthcare sector. Each implant is designed for specific purposes and anatomical locations....
In this blog, we have discussed medical device contract manufacturing service. Additionally, we have highlighted why new medical device companies or startups should opt for this service. Furthermore, we have tried to answer some common FAQs. Contract...