13 Feb Date February 13, 2025 Author Mr. Arunkumar Chokkalingam Case Study 1: U.S. Endotracheal Tube Manufacturer – Achieving 21 CFR 820 Compliance & 510(k) Submission with Medfins International. Client Background This case study focuses on a U.S.-based medical device manufacturer specializing in endotracheal tubes. The c...
10 Sep Date September 10, 2024 Author Mr. Arunkumar Chokkalingam The EU In Vitro Diagnostic Regulation Introduction The EU In Vitro Diagnostic Regulation (IVDR 2017/746) significantly overhauled the regulatory landscape for in vit...
13 Aug Date August 13, 2024 Author Mr. Arunkumar Chokkalingam Unlocking the Secrets of Notified Body Selection: How Medfins International Guides You Through the EU Regulatory Maze The medical device industry in India has undergone significant transformation and growth over the past few years. This growth is p...
11 Jul Date July 11, 2024 Author Mr. Arunkumar Chokkalingam EUDAMED : European Database on Medical Devices What is EUDAMED It's a European Data bank on Medical Devices, is a key element under the EU Medical Device Regulation (MDR 2017...
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...