29 Nov Date November 29, 2024 Author Ms. Sneha Ramasamy What is a Free Sale Certificate (FSC)? An official document issued by the Central Licensing Authorities or State Licensing Authorities that certifies a medical device is...
27 Sep Date September 27, 2024 Author Ms. Sneha Ramasamy Navigating the Regulatory Landscape for Innovative Medical Devices Without a Predicate in India: A Comprehensive Guide India's burgeoning medical device market presents a lucrative opportunity for manufacturers worldwide. However, introducing innova...
30 Aug Date August 30, 2024 Author Ms. Sneha Ramasamy Unveiling CDSCO Insights: Top 10 FAQs from My Professional Journey Q: What are the current audit timelines for medical device regulation, and how have they changed recently? A: The audit timelin...
26 Apr Date April 26, 2024 Author Ms. Sneha Ramasamy Understanding ISO 13485 and Notified Bodies Understanding ISO 13485 and Notified Bodies ISO 13485:2016: The internationally recognized standard for quality management sys...