Medical devices

Must be safe in order for us to be safe

A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
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Examples of medical devices from low to high risk

MDCG guidance on classifications of medical devices
Medical devices are regulated based on not only the country they are made in, but where the the devices are exported and imported. The regulations depend on the governing authority for the country.

From countless guidance documents and videos available online to watch, to training that may be out of a company's and/or personal budget, there are many avenues for complimentary webinars that will also provide an associated record to demonstrate completion. Interested?

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