Resource Center

Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.

Applying ISO 14971 to AI/ML

Applying ISO 14971 to AI/ML

Everyone is aware that ISO 14971 is the gold standard for risk management of medical devices. As the regulatory ...
HACCP Plans

HACCP Plans

The Food and Drug Administration (FDA) better protects the public health by aiding the food supply's safety and ...
Decentralized Clinical Trials

Decentralized Clinical Trials

As of May 2023, the FDA released an updated draft to the decentralization of trials for drugs, biologic products, ...

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