All Features
Peter Cappelli
A recent report showed that 59% of managers said they had received no training on how to be a manager before becoming one. Management professor and director of Wharton’s Center for Human Resources Peter Cappelli says that stunning statistic is compounded by the fact that most of those managers are…
Etienne Nichols
In the United States, the Food and Drug Administration (FDA) is the federal agency tasked with regulating the medical device market and ensuring the safety and effectiveness of all devices for patients.
The FDA classifies medical devices by risk into three categories: Class I, Class II, and Class…
Stephanie Ojeda
An analysis of U.S. Food and Drug Administration (FDA) warning letters by the Food and Drug Law Institute reveals a perhaps not-so-surprising link between training gaps and FDA violations.
It’s one of several factors motivating companies to switch to automated training management software. The…
Kelly Nault, Ko Kuwabara, Yejin Park
Giving and receiving help are essential aspects of organizational life, whether that’s providing career advice or soliciting a colleague’s input on a tricky technical problem that you just can’t solve. Through help exchange, individuals gain access to ideas, resources, and relationships that help…
Gleb Tsipursky
Generative AI, when harnessed correctly, has the potential to revolutionize the way companies operate, innovate, and compete. But the question that arises is how businesses can effectively tap into this potential. The answer lies in setting up an AI center of excellence that combines IT with…
Saurabh Joshi Shripad
Risk assessment and continual process verification (CPV) are fundamental regulatory requirements for pharmaceutical companies to ensure drug safety, efficacy, and quality. While risk assessment involves analyzing, mitigating, communicating, and monitoring risks that could ultimately affect patients…
William A. Levinson
What do quality and productivity have to do with World War III, which we all hope will never happen? The answer is everything. A massive loss of American manufacturing capability between 1945 and 2024 has conceded enormous advantages to aggressor nations that might be inclined to break the peace.…
Jamie Bihary
An internal audit can be an overwhelming prospect, especially if you’re new to a company or internal auditing in general.
The MedTech space is huge, and even the standards that are meant to help, like ISO 13485:2016, cover a lot of ground.
So, if you’re part of the audit team in your company, and…
Jamie Fernandes-ETQ
Generative AI took the world by storm in 2023, from the classroom to the film studio, and the writer’s bench to the White House. Enterprises and creative industries worked to figure out how to leverage it in their operations, while classrooms and government entities struggled to govern its use.
In…
Pierre-Nicolas Disser
With concerns for an economic downturn constantly looming, the global manufacturing industry finds itself navigating through a sensitive time. Once bustling factories, go-to for the world’s largest brands, are experiencing an unexpected lull attributed to multiple factors, including inflation and…
Matthew Zajechowski
Stress is an inevitable part of life, shaping and influencing our every decision, emotion, and action, including the way we communicate. It may induce the silent treatment or cause an emotional outburst, both of which can cause future regret.
Preply, a language learning service, surveyed Americans…
The MEP National Network
The personalized nature of coaching makes it a powerful force for manufacturers. You can employ coaching to improve leadership, enhance performance and teamwork, or address personal and organizational development.
With as many as five generations in the workplace at the same time, and constant…
Mark Hembree
Without raising false alarms, it’s fair to say that password insecurity is a problem that lives near you and is worthy of your attention.
In its article, “139 password statistics to help you stay safe in 2023,” digital security firm Norton cites a report by password manager LastPass that more than…
Kari Miller
Traditionally, quality management in the pharmaceutical industry has strayed away from artificial intelligence (AI) for fear of setting it loose with such sensitive information. They have been cautious of implementing an additional element of intelligence into their process. But will organizations…
Gleb Tsipursky
Are employers walking into a legal storm by enforcing rigid return-to-office (RTO) mandates? The post-pandemic era presents a unique challenge as employers grapple with shifting workforce dynamics. The insistence on a full return to the office without considering individual circumstances could lead…
Master Gage and Tool Co.
Calibration is essential in almost every facet of industrial processes. The calibration process verifies test instrument accuracy by comparison with recognized standards, and measurement validity hinges on one crucial concept: traceability.
Traceability adherence ensures a continuous link between…
Jón Bergsteinsson
Clinical investigations play an important role in your journey of bringing a medical device to market. While the relevant standards are often perceived as difficult and complex, having a good grasp of them makes the process less confusing.
Understanding ISO 14155:2020 is essential. It’s a guide to…
Megan Wallin-Kerth
We all make mistakes. Despite a vigorous editing process, there may even be one in this article! Although everyone makes mistakes, not everyone owns up to them, and thus they miss an opportunity to grow, learn, and—if they appreciate and apply what they’ve learned—consistently improve the quality…
Gleb Tsipursky
In an era when flexibility and autonomy are requirements, financial services leaders are ready to break the chains of traditional office norms. The results of a recent Deloitte and Workplace Intelligence survey make it clear: The future of the financial services sector is hanging in the balance,…
Melissa Stewart
Companies are always looking for ways to bring in fresh ideas and new perspectives. And in an ever-evolving digital world, you can’t blame them. Young talents possess the latest technological skills and insights, which can be incredibly useful in adapting to the times. However, there’s one thing…
Stephanie Hinton
If you’re conducting a clinical investigation of a medical device in a European Union member state, you will be required to submit a clinical investigation report (CIR) along with a summary of the CIR to that member state.
The European Union Medical Device Regulation (EU MDR) lists this as one of…
Stephanie Ojeda
The number of ISO 45001 certificates is growing fast, jumping 54% from 2020 to 2021, according to the ISO Survey.
This occupational health and safety standard is especially prevalent in manufacturing, where managing safety incidents is a core concern from the perspective of protecting workers,…
William A. Levinson
The difference between common (or random) cause and special (or assignable) cause variation is the foundation of statistical process control (SPC). An SPC chart prevents tampering or overadjustment by assuming that the process is in control, i.e., special or assignable causes are absent unless a…
William A. Levinson
Inflation is a serious national issue. Credit agency Fitch Ratings just downgraded the U.S. credit rating—as in the “full faith and credit of the United States”—from AAA to AA+.1 This doubtlessly reflects the fact that our national debt exceeds $31 trillion, or almost $100,000 for every American,…
Mark Graban
I can’t count how many times during the past 20 years I’ve heard executives complain that their people aren’t enthusiastically participating in their lean program. Leaders lament that while the company has spent a small fortune to put everybody through continuous improvement training, hardly…