Kiwa was proud to participate in the GRIT Gandhinagar 2026 conference, “Gujarat to Global: Empowering the MedTech Ecosystem,” held on 23 June 2026 in Gandhinagar, Gujarat, India. The event brought together policymakers, regulatory experts, industry leaders, and medical device manufacturers to discuss how India’s rapidly growing MedTech sector can strengthen its position in global markets.
Are you considering substantiating the clinical data of your device based on an equivalence device? Do you have full access to clinical data for technical, biological and clinically similar devices and you wish to leverage that to prove compliance for another device? This article could help you get a feeling of whether this could be an option.
EN IEC 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance, is a harmonized standard that outlines the essential safety and performance criteria for active medical devices. Incorporating this standard during the design phase of electrical medical devices is crucial.
In the medical device industry, maintaining quality and compliance is paramount to ensure patient safety and product efficacy. Two critical concepts that often arise in this context are Out-of-Specification (OOS) events and Deviations. While both indicate potential quality or compliance concerns, they differ significantly in their focus, triggers, and resolutions.
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