Category: Medical Devices

AI Medical Devices, SaMD Regulations, and 3D-Printed Devices Compliance Challenges for Indian Manufacturers
By Vigilare Biopharma July 31, 2026Medical Devices

AI Medical Devices, SaMD Regulations, and 3D-Printed Devices Compliance Challenges for Indian Manufacturers

In India, there are many AI-based medical devices, SaMD regulations, and 3D‑printed medical devices in the risk-based medical device framework. Rooted in tightened MDR 2017 and emerging CDSCO guidance, however, Indian manufacturers still face major

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Deep-Dive_-Essential-Elements-for-Clear-and-Concise-Labelling-Text-for-Medical-Devices
By Vigilare Biopharma October 1, 2025Medical Devices

Deep Dive: Essential Elements for Clear and Concise Labelling Text for Medical Devices

Medical device labelling is more than just a regulatory requirement—it’s a critical communication tool that ensures safety, usability, and compliance. Whether you’re a manufacturer, distributor, or healthcare provider, understanding the essential elements of clear and

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