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Five Biggest Quality Management Mistakes in the Medical Device Industry

Here’s how you can avoid making them

Sara Adams
Thu, 09/23/2021 - 12:03
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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.

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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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Comments

Submitted by ANUP CHANDRA (not verified) on Thu, 09/23/2021 - 10:25

5 mistakes

After certification most involved get relaxed. Follow up audit by certifying agency is also become formality

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Submitted by Henry Couture (not verified) on Thu, 09/23/2021 - 13:31

Five Quality Mistakes Article

Timely article to provide that 'constant gentle reminder' that a well-oiled Management Review process wins the day!  I've found a Monthly is too frequent, and a quarterly is just right -- allows team to address issues in a timely manner.  The other 4 'mistakes' should be part of the Leadership's dashboard to monitor and ensure proper focus of resources to 'resolve' potential issues.

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