Why Hiring a CDSCO Medical Device Consultant is Essential?
Central Drugs Standard Control Organization is the apex medical device regulatory body in India. Securing a CDSCO medical device license is mandatory for launching your devices in India. India’s regulatory landscape for medical devices is complex, highly technical,...
How to Get CDSCO Import License for Testing Medical Devices?
Importing medical devices for testing purposes is a regulated process. Central Drugs Standard Control Organization (CDSCO) is the apex medical device regulatory body and oversees all medical devices being imported into India. Devices imported for testing, evaluation,...
15 Common EU MDR Pitfalls & Tips to Avoid Them
Common EU MDR pitfalls are recurring mistakes and compliance gaps that medical device manufacturers encounter when implementing EU MDR. These compliance gaps frequently lead to delays in obtaining CE marking, and rejection by Notified Bodies. The transition from the...