15 Feb Date February 15, 2024 Author Mr. Arunkumar Chokkalingam NEW IVD In India, the form for obtaining permission to import or manufacture a new In-Vitro Diagnostic (IVD) medical device is MD-28. Here...
24 Jan Date January 24, 2024 Author Mr. Arunkumar Chokkalingam What is UDI in the EU Context? Definition : The UDI is a series of numeric or alphanumeric characters that provides a globally unique identifier for medical dev...
16 Nov Date November 16, 2023 Author Mr. Arunkumar Chokkalingam Introduction to Technical Documentation under EU MDR 2017/745 Technical Documentation under the EU Medical Device Regulation is a thorough collection of documents proving a medical device's co...
30 Oct Date October 30, 2023 Author Mr. Arunkumar Chokkalingam What is EUDAMED 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...