Media theorist Marshall McLuhan may not have had quality management for medical devices in mind when he coined the phrase “global village” in the 1960’s, but the fundamental interconnectedness of modern society has brought his concept to life. And while technology is at its core, the need for international harmony in the regulatory sphere is arguably a key QMS issue.

Harold Wilson, the former British prime minister, famously said in 1964 that a week was a long time in politics. Just over 20 years later, iconic pop culture figure Ferris Bueller sagely remarked that life moves pretty fast, and if we don’t stop and look around once in a while, we are in danger of missing important events, remarkable moments or the nose on our face.

We are excited to announce the release of ETQ Reliance 2019, a major upgrade to our flagship QMS SaaS product. The latest release of ETQ Reliance includes an entirely new User Interface (UI) and updates that improve personalization and collaboration.

Since its founding in 1992, ETQ has set the standard for delivering best-in-class quality, EHS and compliance management systems for today’s leading organizations. Over the past 25+ years, the company has developed an incredible roster of clients, a strong understanding of the industries they operate in and the expertise required to ensure they provide their customers with only the best products and services. Today, ETQ is excited to announce the next chapter in our story, and I’m thrilled to be leading the charge. 

Patient-centricity is a buzzword in life sciences, part of a push for innovation made difficult by complex regulations and long-standing corporate cultures that favor the status quo.

Compare this to the tech industry, which is constantly developing new, high-quality products that surprise and delight customers. Companies like Apple, Google and Amazon, all of whom have pushed the limit and redefined what it means to be a thought leader.

What can medical device manufacturers learn from these tech giants? Let’s look at 4 of the most important lessons companies can use to improve quality and move confidently into the next era of innovation.

A major misconception about Quality 4.0 is that it is meant to completely replace your current quality management practices.

When I was a kid, I loved reading Highlights magazine. It always had really solid knock-knock jokes there, as well as informative articles and fun craft projects.

The number of warning letters handed out by the U.S. Food and Drug Administration (FDA) has been on a steady rise over the past several years. In fact, the agency handed out more than 100 warning letters in 2016 alone, often after missed opportunities to correct mistakes pointed out in Form 483 observation reports.

Data can be a gift and a curse when it comes to operational excellence. For some companies, ineffective practices make data a barrier to improvement, with too many data points and metrics obscuring the most strategic course of action.

At the same time, data is also a key enabler of operational excellence, helping businesses make sense of the vast quantities of information generated in today’s manufacturing environments. All told, a full 85% of companies aim to be data-driven, yet little more than a third of them are successful.

Today, we’re looking at four ways companies can better leverage data for operational excellence, looking at elements like predictive capabilities, supplier quality management and measuring effectiveness.

The Resource Conservation and Recovery Act (RCRA) is the main U.S. law governing hazardous and non-hazardous solid waste management. The U.S. Environmental Protection Agency (EPA) is responsible for enforcing the law, handing out $200 billion in criminal fines in 2016 over RCRA and other violations.

The problem for manufacturers is that, despite many companies’ hopes of a more relaxed regulatory environment, the potential EPA penalties are more costly than ever. In this post, we’re looking at some of the most common RCRA pitfalls, including how to avoid errors in waste determinations, labeling and storage.