Incomplete or Inaccurate Information: Missing Documents: Not including all the required documents as per the CDSCO guidelines...
It's a European Data bank on Medical Devices, is a key element under the EU Medical Device Regulation (MDR 2017/745) and the In Vi...
Client Background This case study focuses on a U.S.-based medical device manufacturer specializing in endotracheal tubes. The c...
An official document issued by the Central Licensing Authorities or State Licensing Authorities that certifies a medical device is...
Introduction The EU In Vitro Diagnostic Regulation (IVDR 2017/746) significantly overhauled the regulatory landscape for in vit...
Government Authority (CDSCO) The Indian Medical Device Regulation, established by the CDSCO, must be followed by all medical de...
By 2025, the rapidly expanding Indian healthcare sector will generate $280 billion in revenue. One of the top 20 medical device ma...
Definition : The UDI is a series of numeric or alphanumeric characters that provides a globally unique identifier for medical dev...
Technical Documentation under the EU Medical Device Regulation is a thorough collection of documents proving a medical device's co...
What is EUDAMED It's a European Data bank on Medical Devices, is a key element under the EU Medical Device Regulation (MDR 2017...