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NIST
Static force, such as the weight of a person standing motionless on a bathroom scale or the force that an office full of equipment exerts on a high-rise floor, can be easily determined using scales, balances, load cells, and the like because static force doesn’t change over time. It’s…
Etienne Nichols
On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR…
Bryan Christiansen
Creating a well-run facility isn’t as simple as it appears. It requires meticulous planning, dedicated resources, and a keen eye for detail to ensure that all elements, from the largest machines to the smallest fixtures, function as intended.
All these aspects fall under the umbrella term of…
Michael Jarrett
History is filled with tales of courageous and decisive heroes. Individuals like Julius Caesar and Winston Churchill, for example, have led from the front to guide people through adversity and achieve ultimate success. This myth building is especially prominent in business, with stories of…
Ian Wright
It’s been a long and arduous road, but you’re almost ready for that first production run. You made it through supplier selection, your designs and production processes have been finalized, preproduction is finished, and now there’s just one more hurdle to clear: first article inspection (FAI).…
Gleb Tsipursky
Hybrid employees don’t hate the office; they hate commuting to it, surveys show, since for many workers commuting takes more than an hour per day and costs thousands of dollars per year. Peer-reviewed studies find clear associations between longer commute times and lower job satisfaction, increased…
Stephanie Ojeda
Mistakes around standard operating procedure (SOP) management are widespread and costly, especially given the pace of change in manufacturing today.
Consider, for example, an electronics manufacturer that introduces a new product model with updated features and components. This new model requires…
Jones Loflin
One of the things I hear from many people is they want to improve their ability to focus. If they just had a distraction-free environment, they could get the right things done. Well, I’m writing this from a distraction-free environment—one of those booths they have at airports where you can make…
Etienne Nichols
Your company probably has an internal process for a large purchase like an eQMS. In midsize-to-large medtech companies, you’ll likely find this process in the finance department, or perhaps in a dedicated purchasing department operating under finance’s umbrella.
1. Start by learning about your…
Kari Miller
Since 2010, citations for insufficient corrective action and preventive action (CAPA) procedures have been at the top of the list of the most common issues within the U.S. Food and Drug Administration (FDA) inspections, particularly for the medical device industry. Issues can occur while…
Etienne Nichols
Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management system (QMS).
A QMS contains everything that…
Hank C. Andersen
Not many years ago, there was a CEO so exceedingly fond of finding the right strategy that he spent all of his money on consultants to tell him what the strategy should be. One day there came two consultants, and they said they could craft the most magnificent strategy imaginable. Not only would it…
Megan Wallin-Kerth
Business owners and employees alike have long debated over how best to achieve quality standards and what those standards ought to be. However, as much as linear thinking may help when measuring degrees of improvement, increases in profit, or low turnover rates, it can’t tell you that your company…
Aaron Smith
A successful company can’t run without happy and motivated employees. One way you can achieve that is by improving your employees’ uptime. Uptime refers to your employees’ freedom to pursue personal and occupational growth without the burden of preventable injuries. Here is everything you need to…
Stephanie Ojeda
Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that could have been prevented with design controls.
FDA guidance also makes an explicit link between…
ISO
Net zero is our strongest tool yet against the climate crisis. The transition to net-zero emissions presents a compelling solution that offers not only environmental benefits but also economic, social, and health advantages. Failing to act swiftly and decisively risks catastrophic climate change,…
Ethan Mollick
Nano Tools for Leaders—a collaboration between Wharton Executive Education and Wharton’s Center for Leadership and Change Management—are fast, effective tools that you can learn and start using in less than 15 minutes, with the potential to significantly affect your success.
The goal
Adopt a seven…
Sébastien Breteau
Supply chain quality control is a demanding job. Ensuring that products meet specific standards and expectations for safety and customer satisfaction by monitoring and managing the entire supply chain, from raw materials to finished products, must be accomplished consistently and reliably.
At any…
Bruce Hamilton
Last May marked the 35th anniversary of the Shingo Prize, an award bestowed each year to recognize organizations that demonstrate the principles and methods espoused by its namesake, Shigeo Shingo. Although I haven’t made it to every celebration and award ceremony, it turns out that I was the only…
Etienne Nichols
The goal of your MedTech company’s supplier management process should be to ensure a consistent supply of high-quality parts and components that conform to your specifications.
But achieving that goal is easier said than done, and it depends heavily on whether you take a risk-based approach to…
Ian Wright
‘I have a cellphone that doesn’t behave like a phone: It behaves like a computer that makes calls. Computers are becoming an integral part of daily life. And if people don’t start designing them to be more user-friendly, then an even larger part of the population is going to be left out of even…
Ken Voytek
It’s time for U.S. manufacturers to focus on productivity or they will lose their long-term advantage. Productivity is fundamentally about increasing output rather than decreasing costs and inputs while output remains static. We faced this challenge during the 1980s and 1990s but didn’t learn much…
Gleb Tsipursky
A new study from the University of Birmingham has found that managers have developed a more positive outlook on the benefits of hybrid work productivity since the Covid-19 pandemic. The research surveyed 597 managers and found that 51.8% of them agreed that working from home improves employee…
Mike Figliuolo
It’s a great time of year. Beautiful weather, flowers blooming, and 110 bags of mulch to be spread tell you it’s spring. Now is when we traditionally clean our homes and yards. It’s also a great time to clean up your work and professional life.
Face it: We’re creatures of habit and averse to…
Michael King
Medical companies work in an environment of ever-increasing challenge and complexity. Global regulations continue to evolve with advancements in technology and variations in requirements from country to country. This brings unavoidable technical complexity to daily tasks of quality and regulatory…