All News
Since the early 1980s, the automotive industry has used hydraulically actuated (servo-hydraulic) test systems to simulate operating speeds and road conditions for testing OEM components and fully assembled vehicles. These systems have helped unlock vast improvements in the quality, safety, and…
A September 2024 Gallup poll revealed that nearly 30% of U.S. adults have little to no confidence in the safety of U.S. foods at the grocery store. Considering recent recalls, is it any wonder? What good is a quality control program if it doesn’t include food safety?
Boar’s Head’s Jarratt,…
It creates a warm and inviting atmosphere. Its natural grain and color tones have a lively effect and add character to a room. We are talking about classic wood flooring—usually laminate, and optionally with a click system for easy installation.
Scheucher Holzindustrie GmbH, from Mettersdorf,…
In April 2018, the U.S. Food and Drug Administration (FDA) approved the first artificial intelligence-powered diagnostic system, a software program used to detect diabetes-related vision loss.
Since then, the industry has seen explosive growth of AI in medical device manufacturing, which is…
Back in 2023, only 15% of businesses had adopted AI-augmented software testing tools. By 2027, that number is expected to leap to 80%. The reason behind this rapid adoption is clear. The complexity of modern software and products is skyrocketing, and with it, the risks associated with quality…
In the world of operations and quality management, the pressure to act quickly can feel overwhelming. Senior executives are constantly racing against time to meet customer demands, solve problems, and keep shareholders satisfied. In the rush to address immediate challenges, “Ready, aim, fire!” gets…
ISO 27001 is a globally recognized standard for establishing, implementing, maintaining, and improving an information security management system (ISMS). Successfully implementing ISO 27001 can provide tremendous benefits, such as ensuring data security, building trust with customers, and meeting…
In today’s highly competitive global markets, lean manufacturing is no longer something that’s nice to have—it’s a way of life. You can either reduce costs, simplify operations, and improve productivity on a continual basis—or you can lose business to competitors that do.
Lean manufacturing starts…
It’s 2024, and the age of automation has largely taken over our phones, computers, and businesses. This isn’t entirely a bad thing, you understand. It gives us the ability to spend time and money elsewhere—from investing in staff to spending more time on innovating technology rather than whittling…
The ongoing relevance of the quality profession requires evolution and adaptation to meet the needs of the 21st century. Remember, the quality profession originated with the need for inspection to prevent poor quality from reaching customers; this was before it evolved to include metrology,…
Compliance with industry regulations and standards is a fundamental part of medtech. Without proper medical device compliance, companies risk patient harm, litigation, and reputational damage.
Fortunately, compliance with medical device regulations and standards is not an impossible task. A…
Everyone has goals these days. The one that causes more disconnects than any other is a sales goal. It’s a number to hit (either units or dollars or both—the better ones are actually measured in profit dollars rather than revenue dollars). They’re problematic because by their very nature they get a…
In regulated industries like pharmaceuticals, medical devices, and food manufacturing, compliance is crucial for operational excellence. A validated quality management system (QMS) is key to maintaining this compliance. Let’s explore how QMS software streamlines validation and ensures regulatory…
A quality management system (QMS) is at the heart of every successful medtech company. A QMS comprises all the policies, processes, and procedures that ensure the production of safe and effective medical devices—which means that problems with your QMS can quickly become problems with your products…
Is your organization about fun? How often do your customers giggle? How much of your business strategy is about funniness—not just entertainment, but customer experiences made joyful by design? What are your customers’ principal memories of their encounters with your organization?
Before we go too…
In the ever-changing world of quality management, the intersection of innovation and standardization offers both exciting opportunities and tough challenges. Maria, a dedicated and certified quality professional, struggled with the concept of “standardizing innovation”—something that seemed like an…
Struggling with underperforming team members while trying to maintain a positive work environment? To help navigate this delicate situation, we’ve turned to insights from CEOs and human resources managers.
We’ll explore six effective strategies HR leaders use to support and guide underperforming…
Whether you’re a small machine shop or a large multimillion-dollar manufacturing giant, there’s no doubt you use dimensional gauges to maintain the standards for quality in your production.
The accuracy of these dimensional measuring instruments must be periodically checked to ensure that they’re…
Data breaches and cyberattacks are things that small to medium-size manufacturers think won’t happen to them. Yet, according to the Verizon 2023 Data Breach Investigations Report, 43% of all cyberattacks are conducted against small businesses.
If that doesn’t grab your attention, consider this…
While clinical trials are the gold standard for generating clinical data to use as evidence of your medical device’s safety and effectiveness, they are by no means the only way to gather clinical evidence.
Real-world data (RWD), which typically come from routine healthcare delivery or…
Leadership is perilous territory. People’s lives are at stake (sometimes literally). Although avoiding the following seven deadly sins won’t guarantee you’ll be a great leader, succumbing to them will guarantee you’ll have a significant learning moment. (Translation: You’ll fail miserably, but…
In the highly regulated world of life sciences, data integrity isn’t optional; it’s essential. The ALCOA principles—attributable, legible, contemporaneous, original, and accurate—provide a foundational framework for ensuring data are reliable and trustworthy.
With the rise of digital…
Speed is one of the most strategic elements a company can use to attract and retain customers and drive its revenues.
What do I mean when I talk about speed? In this context, speed means dramatically reducing the amount of time needed to complete a task by altering factors such as empowerment,…
Despite their impressive capabilities, large language models (LLMs) are far from perfect. These artificial intelligence models sometimes “hallucinate” by generating incorrect or unsupported information in response to a query.
Due to this hallucination problem, an LLM’s responses are often verified…
(CIMdata: Ann Arbor, MI) -- CIMdata, a global PLM strategic management consulting and research firm, announces the release of a new white paper, “SSI Shipbuilding PLM: PLM Tailored to Unlock Shipbuilding Transformation.” The paper describes the evolving capabilities of SSI’s Shipbuilding PLM as…