The European Medicines Agency (EMA) and the United States FDA have fully implemented the Mutual Recognition ...
ISO 14971 is the ultimate gold standard for risk management for medical devices. It was developed to provide ...
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 ...