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Three Tips for Managing Your Medical-Device Design History File
Your design history file (DHF) is one of the most critical components of your QMS. That’s because the DHF should contain all the product development documentation for a specific medical device. Its purpose is to show regulatory bodies and internal stakeholders that you appropriately followed the…
Mitutoyo America Corporation Introduces Quick Vision Pro Series
(Mitutoyo: Aurora, IL)-- Mitutoyo America has released the Quick Vision Pro Series, the latest generation of Mitutoyo Vision Measurement Systems. Quick Vision Pro Series machines are packed with high-performance technologies that greatly improve 3D noncontact measurement and productivity. The new…
Medical Contract Manufacturer Proves Business Case for Robotic Gauging of Machined Parts
(New Scale Robotics: Victor, NY) -- New Scale Robotics has released a new case study video with Orchid Orthopedic Solutions, a medical contractor manufacturer in Bridgeport, Michigan. Orchid uses New Scale’s Q-Span Robotic Gauging System to automate QC inspection of its machined surgical drills.…
Jedox Named an Overall Leader in Customer Experience and Vendor Credibility
(Jedox: Freiburg, Germany) -- Jedox, an award-winning provider of enterprise performance management (EPM) solutions for Financial Planning and Analysis (FP&A), has been named an Overall Leader for Customer Experience and Vendor Credibility in the 2022 Wisdom of Crowds Enterprise Performance…
Should the Residuals Be Normal?
The analysis of residuals is commonly recommended when fitting a regression equation to a data set. It has even been recommended for the analysis of experimental data where the independent variable is categorical (i.e., treatment levels). In both of these contexts, it has been said that the…
How Pharma Quality Leaders Navigate Shifts and Instigate Change
The pharmaceutical industry has seen significant upheaval and disruption during the past several years. These changes are due in part to the impacts of Covid—for example, interruptions in the supply chain and overwhelming market demand for shortened production times. They are also being driven by…
Optical Inspection for Defect Detection on Cast Parts
(Marposs: Auburn Hills, Michigan)-- Marposs, a world leader in measurement, inspection, and test technologies, announces the availability of noncontact machine-vision measuring systems able to detect the presence of defects such as porosity, scratches, and depressions on the sealing surfaces of…
Small Businesses: Keeping Up With Today’s Economy
Standards are not for just the minority of businesses with thousands of employees. According to the World Bank, micro, small, and medium-sized enterprises (MSMEs) make up more than 90 percent of all companies and account for up to 70 percent of total employment. In developing countries, small…
Food Processors: Tubular Drag Conveyors Double the Volume
Food processors have long sought a safer, more energy-efficient means to convey product with less spillage, breakage, or downtime due to necessary cleaning and maintenance. Although tubular drag conveyors have offered these desired attributes compared to belt, bucket, or pneumatic systems, many in…
Robot Sales in North America Continue Record Surge Into 2022
(Association for Advancing Automation [A3]: Ann Arbor, MI) -- North American companies started the year by purchasing the most robots ever in a single quarter, with 11,595 robots sold at a value of $646 million. According to the Association for Advancing Automation, these Q1 numbers represent…
The New Project-Based Economy
In an ideal world, a project economy would empower people with the skills and capabilities needed to turn ideas into reality. In that world organizations would deliver tremendous value to exceed stakeholders’ expectations by successfully completing projects. Yet research shows that only 35 percent…
Fewer Than Half of CEOs Are Back at Office Full-Time
(Marcum LLP: New York City) -- Fewer than half of midmarket CEOs have returned to the office full-time, and about a quarter plan to work a hybrid schedule indefinitely, according to the latest CEO survey from Marcum LLP and Hofstra University’s Frank G. Zarb School of Business. The survey,…
Bringing Metrology Into Medical Device Production
This article has been republished with permission from Medical Plastics News. While ISO 13485 sets the standard for quality management systems (QMS) in medical device manufacturing, metrology is often treated as an afterthought and used simply to validate products and detect defects at the end of…
Cadenas and Kubotek3D Partner to Enhance KeyCreator Efficiency With Digital Catalogs of Purchased Components
(Kubotek3D: Marlborough, MA; Cadenas: Augsburg, Germany) -- Kubotek3D and Cadenas have partnered to provide KeyCreator mechanical and manufacturing design users access to an enormous selection of 3D and 2D component geometry from 3Dfindit.com, the technical search engine powered by Cadenas. From a…
Webinar: Aligning Your Information Security Management System Framework With TISAX Controls
(Omnex: Ann Arbor, MI) -- Omnex is hosting the webinar, “Aligning Your Information Security Management System Framework With TISAX Controls” on July 29, 2022, at 11 a.m. Eastern. To bolster information exchanges and data transfers, many organizations are requiring their external providers to…
Thinking Inside the Box: Why Virtual Meetings Generate Fewer Ideas
Even if the pandemic abates enough for a return to normal, all evidence indicates that a substantial share of Americans will continue to work from home, relying on videoconferencing to team up. Yet, while the ease of gathering virtually has made the shift to widespread remote work possible, a new…
Traditional Offices Exacerbating Recruitment Struggles
(Unispace: London) -- Following reports that older businesses are finding it more difficult to fill skills gaps, Unispace, a global leader in creating custom workplaces, warns that a lack of workplace evolution is hindering talent attraction for more established businesses. In research unveiled by…
From Wax Light to Moonlight
One of the unexpected rewards of working at NIST has been the opportunity to see other disciplines through the NIST prism of measurement science and standards. By working with NASA scientists, astronomers, oceanographers and geologists, I’ve had the opportunity to witness the lives of scientists in…
BASF Project Implementation Manager Shares Update on Apprenticeship Program
Many industries are embracing apprentice and trade programs in efforts to create a strong and reliable workforce for the future—and the manufacturing field is no exception. The BASF apprenticeship program began as a way for young professionals to find success through practical on-the-job training.…
Six Packaging Quality Control Checks
Staying on top of packing quality-control measures can have positive ramifications for companies. For starters, products are more likely to arrive undamaged if they're in appropriately robust boxes. There’s also a safety element involved. Suppose a fragile item shatters in transit due to improper…
LK Metrology to Exhibit New CMM and Metrology Solutions at IMTS
(LK Metrology: Castle Donington, UK )-- LK Metrology, the global designer and manufacturer of Coordinate Measuring Machines (CMMs), metrology software, and associated CMM accessory products, will be exhibiting a variety of new products at McCormick Place in Chicago for the 2022 IMTS Show in…
Investigating Coriolis Mass Flow Meters as Field Reference Meters
(NIST: Gaithersburg, MD) -- Commercial metering systems are ubiquitous in the commercial marketplace (to dispense liquified products, from gas and water to food products and agricultural chemicals). Customers and businesses alike rely on these meters to monitor and deliver their products…
Interview With ASQ CEO Ann Jordan
This is the first installment of a five-part series.   In May, Quality Digest editor in chief Dirk Dusharme and I attended ASQ’s 2022 World Conference on Quality and Improvement (WCQI) in Anaheim, California. It was the first in-person conference since Covid hit the world, and attendance was just…
Standards Help Keep Firefighters Safe
‘Firefighters are heroes.” We hear it all the time, from children, the media, and young people looking for a rewarding career. It’s probably something you’ve said or thought yourself at one time or another. These brave men and women put their own safety on the line every day to protect their…
Cost-Effectiveness in Composite Extrusion Modeling (CEM) with PA6GF30 Polyamid
(AIM3D: Rostock, Germany) -- The composite extrusion modeling 3D process shows great potential to be cost-effective compared to alternative 3D printing processes. In cooperation with the University of Rostock, the startup company AIM3D has conducted a series of tests with PA6GF30 (BASF Ultramid…

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