Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm
  • info@omcmedical.co.uk

Get In Touch:

Get In Touch:

  • info@omcmedical.co.uk
Youtube Linkedin Facebook Instagram
Call Us Now:
+44 2080667260 sales@omcmedical.com

Articles

Home
Blog Standard
Page 24
05Feb 2024
EU, EU MDR, FDA, Regulations, USA Cubicdesignz Comments: 0

Software As a Medical Device and Its Clinical Evaluation

As technology advances across all healthcare fields, Software plays a significant role in all products. It is widely integrated into digital platforms serving both medical and non-medical purposes. Medical device software is one of three types of Software related to medical devices. The other two types of medical device software include Software that is an integral part of the medical device (medical device software) and Software used in manufacturing or maintaining the medical device. Software...
Read More
Regulation (EU)
05Feb 2024
Regulations, News admin Comments: 0

Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023 

Introduction Recent amendments to Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), have introduced significant changes to the timelines and conditions for placing certain medical devices on the market or putting them into service. This comprehensive analysis explores the key points of these amendments, focusing on the intricate timeline considerations.  Paragraph 3 Amendments Paragraph 3 has undergone crucial revisions, introducing new provisions (3a to 3g) that o...
Read More
05Feb 2024
News, Trending Now Cubicdesignz Comments: 0

Navigating Biologic Product Registration in Thailand: TFDA Requirements, Procedures, and Validation Process

TFDA Requirements for Summary Product Characteristic (SPC) Thailand, governed by the Drug Act B.E.2510. The key points are as follows 1. Legal Basis and Scope Article 79 of the Drug Act mandates that no drug can be manufactured or imported into Thailand without obtaining marketing authorization from the Thai Food and Drug Administration (TFDA).  Articles 80, 81, and 82 of the Drug Act specify the application dossier requirements, including quality, non-clinical, and clinical infor...
Read More

Enquiry Now

    This will close in 0 seconds