May 14, 2025
Aristotle once said, “Quality is not an act; it’s a habit.” This is the first in a series of articles on Quality Culture in the Medical Device Industry. In this first article, we focus on the unique challenges we face in creating a strong quality culture in the medical device industry and considerations for the […]
May 8, 2025
“How did you go bankrupt?” Bill asked. “Two ways,” Mike said. “Gradually and then suddenly.” -Ernest Hemingway, The Sun Also Rises. Gradually, Then Suddenly In Ernest Hemingway’s novel “The Sun Also Rises,” the quote above refers to the character’s financial predicament. However, most of us can see that this sentiment resonates far beyond financial matters and […]
May 8, 2025
The following article is a transcript from the “How is Quality Pulse different from other tools on the market?” video with Teresa, Kenneth, and Jerry. Jerry Appert: Great, great discussion. When you think about all of the different applications and use cases that you both articulated so nicely, maybe one of the questions I started […]
May 8, 2025
The Quality Pulse® culture diagnostic tool is appropriate for all companies in biopharma and pharma, in regulated consumer products, in devices, and in combination products. Companies that do not have a culture supportive of enabling quality…they suffer poor health authority outcomes, there is a lack of trust amongst healthcare providers and patients, there are unplanned […]
May 2, 2025
The following article is taken from June 15th Webinar – “Create a Quality Culture data to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives”. Challenges of Weak or Ambiguous Quality Culture Data Now let’s look at a third quality culture scenario, where you have a weak or ambiguous culture. Notice in this one that […]
May 1, 2025
Using Quality Pulse® has several use cases that add value to an organization. I’ll give 4 as an example, here. Quality Systems Improvement Initiatives The company is undertaking a quality systems improvement initiative in which they are revising their procedures and systems. It may be driven by a regulatory audit, an internal audit, continuous improvement, […]
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