At Greenlight Guru, we collectively have hundreds of years of experience in medical device quality management. We’ve all seen some great successes during our time in the industry—high-quality medical devices that improved the quality of life for countless people around the world. But we’ve also seen plenty of mistakes, especially when it comes to quality.

Not only have we seen actions (or inactions) that contravene industry standards, but we’ve also encountered issues that have the potential to undermine a company’s success entirely.

Quality management is the cornerstone of medical device manufacturing. There is simply no way to overstate how essential quality is to bring a medical device to market and keep it there long term.

So, let’s take a look at the five biggest quality mistakes we see medical device manufacturers making and how you can avoid them.

1. Conducting infrequent management reviews

How close is your management team to the inner workings of your quality management system (QMS)?

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