Medical equipment is a necessary yet substantial investment for any health system.

The buzz has begun. ISO 9001 is being revised. There hasn’t been a revision in about 10 years, so it’s due—if not overdue. Still, there are individuals who don’t understand the justification or the purpose of the revision. After all, it’s a perfectly good standard.

The cost of poor quality can be devastating to business: Failed quality control costs manufacturers anywhere between

The U.S. Food and Drug Administration (FDA) emphasizes the importance of being prepared for device recalls.

Implementing an automated compliance management solution is a mammoth undertaking with high stakes and potentially high returns for those who navigate the process successfully.

As U.S. Supreme Court Justice Louis D. Brandeis famously wrote, “Sunlight is said to be the best of disinfectants.”

An internal audit can be an overwhelming prospect, especially if you’re new to a company or internal auditing in general.

Reactive maintenance is a form of physical asset management in which maintenance is only performed on equipment or machinery when it malfunctions or fails entirely.

Formal complaint management is a requirement in regulated industries such as medical device and pharmaceuticals under U.S. Food and Drug Administration (FDA) and other international regulations.

ISO 9001 has begun its revision process. In the next few months, all eyes will be riveted on that arena as everyone seeks to anticipate the changes and what they’ll augur for their own quality management systems. The attention is not undeserved.