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Under FDA regulations device labelers must generate a unique device identifier (UDI) for each of their products ...
Classification of certain medical devices may be predisposed to ambiguities related to which classification type ...
Complaint management systems are a necessary part of a Quality Management System. Complaint management is defined ...
The FDA divides Life science products up into different categories with their associated centers. These centers, ...
Every company knows the importance of maintaining accurate and complete data of a high quality over periods of ...
FMEA is an acronym that stands for Failure Mode Effect and Analysis which is a method for determining any and all ...
When issues occur that have the potential to impact product quality, Quality Assurance Reports (QAR) are generated ...
Evolution is the process of how a species changes over time in response to their environment. Often termed ...
The FDA has recently been putting a much greater emphasis on working smarter not harder when conducting clinical ...
Maintenance of equipment is always essential to any manufacturing process. Breakdowns can wreak havoc on any ...
Prior to drugs being commercially available, manufacturers often conduct pre-clinical studies to obtain data ...
While having robust compliance policies and procedures in place is essential for meeting regulatory requirements, ...
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