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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.
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Whenever risk is identified whether it is part of a process or the design of a product, mitigation of the risk ...
It has been a wild past two years trying to figure out what products can mitigate, treat, diagnose or even cure ...
Since 2016, the 21st Century Cures Act (Cures Act) has been implemented to expedite medical product development ...
Many microbes are harmless to humans, but some can cause serious health problems. Microbes can spoil food, ...
Post-market surveillance is necessary for ensuring compliance as regulatory bodies have the authority to impose ...
Submitting a 510k for a medical device can be a long and confusing process. When a 510k is submitted the device ...
The COVID-19 pandemic has changed the world by disrupting global supply chains and impacting human health. This ...
A Certificate of Analysis, CoA, is a document, usually issued by an organization’s quality department, that ...
A deviation is any unwanted event that differs from the approved processes, procedures, instructions, ...
Continuous improvement is the ongoing improvement that can occur in all settings and many aspects of a company. It ...
Whether it is an SOP or a test report, there are certain practices that everyone should follow in order to create ...
Many companies in the industry have been preparing for the In Vitro Diagnostic Regulation (IVDR) rollout since it ...
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