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Clinical Evaluation Report

Medical Devices – Considerations for preparing a Clinical Evaluation Report (CER)

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Overview Medical Device manufacturers must demonstrate the safety, efficacy, and quality, of the product and that it functions as intended without endangering the user or patient. The European Medicines Agency (EMA) mandated a clinical evaluation report (CER) that is required to obtain a CE marking for devices that are to be marketed within the European […]

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Cardiovascular Medical Device Regulation in FDA

Overview on Cardiovascular Medical Device Regulation by the FDA

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According to the World Health Organization (WHO), cardiovascular diseases (CVD) are the leading cause of death around the world. In 2019, nearly one-third of all global deaths were attributed to CVD-related death; 85% were as a result of stroke and heart attack (1). Over the last few decades, cardiovascular devices have emerged as an important

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Pharmacovigilance

India’s New Drugs, Medical Devices and Cosmetics Bill 2022

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Drug laws & regulations in India have roots that are almost 80 years old. India still follows drug laws that were framed in pre-independence time through Drugs & Cosmetics Act – 1940 and Rules 1945. The laws & rules have frequently been amended to address the challenges posed by Indian pharma Industry. However, the basic

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