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FDA Guidance Documents

FDA Guidance Documents

If you are in the Life Sciences Industry you have heard of FDA Guidance Documents, and specifically, if you are in ...

Health Canada’s Special Access Program for Medical Devices

Health Canada’s Special Access Program for Medical Devices

Part 2 of the Canadian Medical Devices Regulations under the Food and Drugs Act allows for health care ...

Advancements in the FDA’s Safety and Performance Based Pathway

Advancements in the FDA’s Safety and Performance Based Pathway

One of the FDA’s initiatives for 2021 is to streamline the 510(k) pathways, allowing more efficient access to new ...

Article 59 Under the EU MDR

Article 59 Under the EU MDR

The EU regulators delayed implementation of the EU MDR by a year with its new date of application now being May ...

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