Category: News & Blog

News and Events for industries such as medical device manufacture

Why Privacy and Security are Essential in SaMD

Digital health technologies such as wearables, connected medical devices, and Software as a Medical Device (SaMD) are massively transforming healthcare. Significant innovations in IoT sensors, smart devices, and other small communication devices are driving...

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To CAPA or not to CAPA? That is the question…

CAPA – Corrective and Preventive Action Within the medical device industry, if not carefully administered and messaged properly within the company, Corrective and Preventive Actions are often perceived by employees as “black eyes” on company performance....

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FDA Cleared

FDA Cleared vs FDA Approved

FDA Cleared vs FDA Approved. Let’s dive in! There’s a big distinction between a drug or medical device that’s been FDA cleared and those that are FDA approved. Given that more and more medical device products are...

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