Resources

As Artificial intelligence (AI) continues to grow, the health care industry is beginning to explore the benefits it can bring. With the potential to advance medical product development, improve patient...

The FDA recently issued the Final Rule for the Quality Management System Regulation (QMSR) that amends the current medical device cGMP requirements of the Quality System (QS) regulation (21 CFR...

In an interview with Pharmaceutical Technology®, Susan Schniepp, distinguished fellow, Regulatory Compliance Associates®, and co-chair of board of directors, Parenteral Drug Association, expands on the importance of maintaining a robust...

Measuring the impact of the FDA's Regulation Proposal With recent developments in technology, we have seen artificial intelligence and machine learning more commonly used across all aspects of our lives....

Companies within the life sciences industry have been increasing their use of third parties to manage postmarket surveillance activities in recent years. If you are thinking about outsourcing some of...

When you scale your Design Controls appropriately to the complexity and size of your company, it makes it easier to manage the scope of everyday work needed to keep your...