4 Risks of Relying on Automated Dimensioning Functions for Medical Device Drawings
Automated dimensioning functions in 3D CAD software may seem like a great way to save time. With a few clicks of a mouse, dimensions populate across your drawing,…
Lessons learned in robot-tending coordinate measuring machines (CMMs) translate well to a self-correcting multi-tasking machining process.
Stocked with an array of multi-spindle, multi-axis and otherwise multifunctional metalcutting equipment, Lowell Inc. is worth a visit for anyone interested in machining medical devices…
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.
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…
Automated dimensioning functions in 3D CAD software may seem like a great way to save time. With a few clicks of a mouse, dimensions populate across your drawing,…
Analyzing data for process qualification is an essential practice of medical device manufacturing. It’s also an exercise in copy, paste and patience. There are a lot of data…
Successful first article inspections are essential to successful medical device manufacturing. As part of first article inspection (FAI), medical device manufacturers inspect the first part off a machine…
To continue building relationships with our customers, Brandon Mitchell has joined the Lowell team as sales engineer for orthopedics. Brandon brings 15 years of experience building customer accounts…
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.