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Medical Devices

Is my product a Medical Device? – Knowing the difference

Determine if your product meets the Definition of a device.

Medical Devices

Food and Cosmetics

We takes great pride and pleasure in helping food and cosmetics companies to prevent global regulatory warning letters.

Medical Devices

Invasive Devices

There are so many types of invasive devices in the market! Not all have the same regulatory pathway. Here is a situation

Medical Devices

Active devices

A medical device company asked Elexes to prepare a regulatory strategy for an active device.

Medical Devices


Here are a few milestones to keep in mind with wearable technology!