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Creating a clear and compliant organisation chart is essential for medical device companies and related industries. It helps define roles, responsibilities, and reporting lines, ensuring smooth operations and regulatory compliance. This post explains how organisation charts should be structured according to key standards: ISO 13485, EU MDR, Indian MDR-2017, 21 CFR 820, and MDSAP. It also highlights practical templates and examples to help you build or improve your organisatio

The medical device industry operates under strict regulations to ensure safety, effectiveness, and quality. One key regulation shaping this landscape is the 2017 Medical Device Rule. This rule introduced important requirements that manufacturers, importers, and distributors must follow to maintain compliance and protect public health. Since its implementation, there have been several updates reflecting technological advances and regulatory improvements. This post breaks down

The Tsutsugamushi rapid test card is a diagnostic tool designed to detect scrub typhus, a disease caused by the bacterium Orientia tsutsugamushi. This illness is transmitted through the bite of infected chiggers and is common in parts of Asia and the Pacific. Early diagnosis is crucial because scrub typhus can lead to severe complications if untreated. This post explains the intended use of the test card, its clinical significance, sensitivity and specificity, and potential r