Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management system (QMS).

Manufacturers understand that their businesses won’t grow if their workforces don’t grow along with them.

Not many years ago, there was a CEO so exceedingly fond of finding the right strategy that he spent all of his money on consultants to tell him what the strategy should be.

Business owners and employees alike have long debated over how best to achieve quality standards and what those standards ought to be.

What are the stories we tell ourselves? It’s a simple question, yet one rich with possibility.

You folks know I love asking questions.

The end of Covid-19 workplace disruptions has ushered in a fresh set of challenges for organizations.

Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that could have been prevented with design controls.

Net zero is our strongest tool yet against the climate crisis. The transition to net-zero emissions presents a compelling solution that offers not only environmental benefits but also economic, social, and health advantages.

Pick a problem—any problem. As soon as you have one without an immediate answer, we can begin.