The industry leader in the development and production of implantable medical devices

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Articles

Automated Data Analysis: Making the Case

Orthopedic Design & Technology Magazine

Shifting to automated data analysis for process qualification activities can improve the effort for manufacturers and their customers in several ways.

Lowell’s manufacturing team needed to start making a customer’s part on a new machine. The newer mill/turn machine was automated and would save a lot of machining time versus the original milling machine, but it required reprogramming the part.

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Articles

Keys to a Successful First Article Inspection

Orthopedic Design & Technology Magazine

First article inspection (FAI) is a necessary step to ensure a manufacturing process will create a medical device that works as designed and meets requirements. It is a near-to-100-percent inspection of the first part that comes off a machine. The data and measurements gathered from FAI become part of the medical device file, which is required for FDA submissions and ISO 13485.

The FAI also builds confidence in the manufacturing process. Once it is submitted and approved, it’s assumed the same process will be in place for every part produced after that.

From a contract manufacturer’s perspective, a smooth FAI is important to its OEM customer’s satisfaction…

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Articles

The Eleven Steps of Metrology Matching

Orthopedic Design & Technology Magazine

Metrology matching is a process that aligns two separate inspection systems—typically your system and a supplier’s—to ensure consistent results. The article written by Lowell…

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News & Events

What innovation!! I toured Lowell two weeks ago and could not have been more impressed with your other examples of innovation, namely the robotics utilized in the QA lab and in the laser marking area. We are going to be installing our own hi-definition cameras in our QA lab soon. I’ve copied my QA faculty for them to enjoy your video.

Academic dean
technical college