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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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Nonconforming products happen but managing them before they spin out of control is important. With QualiPro you ...
The U.S. Food and Drug Administration is offering another opportunity for stem cell clinics to work with the ...
The $40 billion dietary supplement industry is still growing making it a market you may want to take advantage of, ...
FDA regulates the labeling and advertising of all pharmaceutical products; however, it regulates the labeling of ...
Having a good CAPA management system is a key element in making sure your CAPA process is successful. QualiPro has ...
After the shutdown of a major contract sterilization facility in Illinois, and another one in line to close its ...
CAPAs are often the most dreaded task to complete and the words “open a CAPA” can bring audible sighs and groans, ...
FDA has issued a proposed rule to up classify surgical staplers for internal use as class II medical devices, ...
Ensuring you have a robust Quality Management System (QMS) is the first step in maintaining compliance with both ...
Our Sr. Quality Engineer Matt Ward explains how to build a strong Design History File for your product by incorporating human factors engineering into the design controls and risk management plan for your product. Learn how risks can be mitigated in the early stages of product development by integrating HFE into the design of your product.
Our RA Manager Song Seto guides you through the FDAs pathway to get your combination product to the US market. Learn more about the combo products pre-market submission reviews and the other mechanism devised by the FDA and things that you should include in your pre-market submission.
China is considered to be one of the many booming medical device markets with its continually increasing ...
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