Call Us 763-425-3355 Search THE INDUSTRY LEADER IN THE DEVELOPMENT AND PRODUCTION OF IMPLANTABLE MEDICAL DEVICES WATCH VIDEO WHY WORK WITH LOWELL QUALITY Our quality assurance program combines data-driven manufacturing and validation, advanced technology and staff expertise. TECHNOLOGY Lowell makes ongoing investments in technology to manufacture and test your finished components and assemblies. PROCESS Our proven manufacturing process helps improve time to market through profile tolerancing, GD&T, critical feature confirmation and design intent. EXPERIENCE At Lowell, everything starts with our people — experienced, trained, professional, precise. 0 CNC machining centers 0 square feet of manufacturing space 0 years in business RESOURCES Go to Resources 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. Read Article 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… Read Article 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… Read Article NEWS & EVENTS View all News Automation Reduces Data Analysis Time during Process Qualification in Medical Device Manufacturing Wednesday, November 17, 2021 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… Read More 4 Keys to Success with First Article Inspections for Medical Devices Monday, September 20, 2021 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… Read More Lowell Introduces Brandon Mitchell as Its New Sales Engineer Monday, August 02, 2021 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… Read More 3 Tips to Reduce Orthopedic Implant Manufacturing Lead Time Wednesday, June 02, 2021 Reducing lead time for orthopedic implant medical devices is one of the top priorities for our customers. It’s understandable to want to know exactly how long a process… Read More LOWELL NEWSLETTER Get highlights of the most important news delivered to your email inbox 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 13485:2016 Registered FDA Registered #2134470 LOWELL, INC. 9425 83rd Ave N Minneapolis, MN 55445 763-425-3355 © 2021 Lowell Inc.