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Author Archives: Mr. Arunkumar Chokkalingam

Medfins International > Articles by: Mr. Arunkumar Chokkalingam
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...
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0 Comments Author Mr. Arunkumar Chokkalingam
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...
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0 Comments Author Mr. Arunkumar Chokkalingam
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...
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0 Comments Author Mr. Arunkumar Chokkalingam
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...
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0 Comments Author Mr. Arunkumar Chokkalingam
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...
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0 Comments Author Mr. Arunkumar Chokkalingam
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...
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0 Comments Author Mr. Arunkumar Chokkalingam
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...
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0 Comments Author Mr. Arunkumar Chokkalingam
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...
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0 Comments Author Mr. Arunkumar Chokkalingam

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  • Blog 24

Recent Posts

  • The Role of Indian Authorized Agent in Medical Device IndustryApril 8, 2025
  • Case Study 1: U.S. Endotracheal Tube Manufacturer – Achieving 21 CFR 820 Compliance & 510(k) Submission with Medfins International.February 13, 2025
  • MD-27 PermssionJanuary 29, 2025
  • Class A and B notified medical device manufacturing registration in India.January 3, 2025
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