Introduction to Technical Documentation under EU MDR 2017/745 Technical Documentation under the EU Medical Device Regulation is...
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Introduction The EU In Vitro Diagnostic Regulation (IVDR 2017/746) significantly overhauled the regulatory landscape for in vit...
Q: What are the current audit timelines for medical device regulation, and how have they changed recently? A: The audit timelin...
The medical device industry in India has undergone significant transformation and growth over the past few years. This growth is p...
In the Indian medical device regulatory landscape governed by the Central Drugs Standard Control Organization (CDSCO), an "endorse...
Incomplete or Inaccurate Information: Missing Documents: Not including all the required documents as per the CDSCO guidelines...
What is EUDAMED It's a European Data bank on Medical Devices, is a key element under the EU Medical Device Regulation (MDR 2017...
Class A non-sterile non-measuring medical devices - Final notification GSR 777(E) was released by the Indian Ministry of Health an...
Understanding ISO 13485 and Notified Bodies ISO 13485:2016: The internationally recognized standard for quality management sys...
By 2025, the rapidly expanding Indian healthcare sector will generate $280 billion in revenue. One of the top 20 medical device ma...