How We Create Quality Medical Devices


The medical device industry is filled with checks and balances to ensure all products are safe and effective. At MediSurge, we go above and beyond with our quality measures to make sure your patients get the best experience possible.

We wanted to give you an inside look at some of the specific quality measures we follow to create medical devices of the future. Keep reading for a breakdown of some of the most important steps in our quality process.

Proactive Measures

Proactive quality measures are just as important, if not more important than reactive measures. Because of this, we focus on key areas that let us spot inconsistencies before they ever become an issue.

Our production manager spends their entire shift inside of our Class 7 Cleanroom. From this position, they’re equipped and empowered to review parts, paperwork, and the work of other team members. If they see anything that’s below expectations, it can be corrected before it ever leaves the clean room.

Similarly, if any team member notices something that may need correction or isn’t in line with our quality standards, they are empowered to halt production until the situation is inspected and handled. It’s just another way that we work together.

Reactive Measures

One of the key reactive measures that we rely upon is the monitoring of trending metrics. Since we keep a close eye on the most important metrics, we can react quickly to unfavorable trends. Plus, since we’re tracking these numbers over time, we can improve our processes for fluctuations, even if the numbers are still within acceptable limits.

For example, we had a product family that ran at less than 1% scrap in 2018. In the first three months of 2019, that number jumped to a 5.5% scrap rate. Our trending metrics identified it quickly, which meant the MediSurge team could combat the issue by opening a CAPA (Corrective Action and Preventative Action).

After three months with the implementation of corrections to fix the issues, our scrap rate was back down to 1%.

We also look closely at all customer concerns. Our production team members, Quality and engineering team work in the same building, so we can make changes or improvements efficiently and effectively. That helps us keep our Customer Complaint Rate low.

The industry standard for Customer Complaint Rates is around 3-5%. Our rate for 2019 is 0.014%, and our company rate since we started selling in January of 2017 is 0.035%. Since our rate is so low, we can address every concern that we receive, unlike companies that get buried in complaints.

Our team is dedicated to designing, manufacturing, and supplying high-quality medical devices that we can all be proud of. We understand that our day-to-day jobs have the power to impact and change lives for the better. That’s why we put quality measures above all else, to ensure that the impact we make is a wonderful one.

Do you need a team of professionals who can help you design, develop, or manufacture your next great idea? Reach out to us today. We’d love to learn about your medical device needs.

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