Client Background This case study focuses on a U.S.-based medical device manufacturer specializing in endotracheal tubes. The c...
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Introduction The EU In Vitro Diagnostic Regulation (IVDR 2017/746) significantly overhauled the regulatory landscape for in vit...
The medical device industry in India has undergone significant transformation and growth over the past few years. This growth is p...
What is EUDAMED It's a European Data bank on Medical Devices, is a key element under the EU Medical Device Regulation (MDR 2017...
In India, the form for obtaining permission to import or manufacture a new In-Vitro Diagnostic (IVD) medical device is MD-28. Here...
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...
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...