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Case study

Creating a Regulatory Strategy for Software as Medical Device

Post thumbnail Creating a Regulatory Strategy for Software as Medical Device

A mobile diabetes software app for patients with diabetes to assist them in the management of their disease by monitoring blood glucose levels, activity, food intake and insulin. Client approached VCLS for strategic and regulatory assistance for Medical Device Software development and certification (CE) mark for the EU market.

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Our Expertise

Within a rapidly evolving regulatory scene, medical devices are under high scrutiny. Regulatory requirements are currently being reinforced, in particular to ensure patient safety.

Medical Devices