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 ...
Our RA Manager Song Seto guides you through the FDAs pathway to get your combination product to the US market. ...
China is considered to be one of the many booming medical device markets with its continually increasing ...
EMMA’s EMEA Regional Director Joseph Yammine explains how the EU’s General Data Protection Regulation applies to ...
It seems like everyone and their dog are using products containing CBD, but are they safe, effective, and in ...
India’s medical device market is growing exponentially. The medical device industry in India is presently valued ...