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Everyone is aware that ISO 14971 is the gold standard for risk management of medical devices. As the regulatory ...
A Biosimilar is essentially a biologic product that is similar and has no clinically significant difference in ...
Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing healthcare, offering unprecedented ...
The FDA’s guidance document on the use of ISO 10993-1 was updated this month with some crucial information for ...
Effective design controls are fundamental to producing safe and effective medical devices. They not only help ...
The 510k program is by far the most popular medical device pathway, and as MedTech has continued to modernize and ...
In the USA, gene therapy products are regulated as biological products by the FDA’s Center for Biologics ...
The Food and Drug Administration (FDA) better protects the public health by aiding the food supply's safety and ...
The Food and Drug Administration (FDA) better protects the public health by aiding the food supply's safety and ...
As of May 2023, the FDA released an updated draft to the decentralization of trials for drugs, biologic products, ...
Ever since FSMA was signed into law in 2011, there hasn’t been another major reform for food safety; the HFP is ...
Most people are familiar with, or have at least heard of, the Health Insurance Portability and Accountability Act ...
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