Five Common Regulatory Pitfalls in the Medical Device Industry
What’s your favorite regulatory pitfall? I know that’s a strange question, but if you’ve spent much time in the medical device industry, there are likely a few that come to mind.
What’s your favorite regulatory pitfall? I know that’s a strange question, but if you’ve spent much time in the medical device industry, there are likely a few that come to mind.
Once hailed as both an ethical mandate and a strategic necessity after the upheaval of 2020, diversity, equity, and inclusion (DEI) initiatives now face intense scrutiny and pushback.
The pharmaceutical industry and the medical device industry have unique ways of defining terms like deviation and nonconformance. Often, this leads to confusion about how events should be classified and managed.
Keeping quality high in today’s fast-moving production world is a big challenge. Traditional quality checks have worked well, but they can be slow, require a lot of work, and are prone to mistakes.
How do health and safety incidents affect your business? If a worker is injured or becomes ill, what kind of disruption does it cause? Is your productivity affected? What’s the effect on other workers in terms of workload or psychological health and well-being?
Engraving of Samuel Colt, 1885.
Innovation is vital to the success of all businesses. Innovate or perish is the new mantra. Leaders must perpetually reinvent their processes, products, and services, because they typically have multiple competitors offering similar offerings.
Manufacturers face a critical challenge: capturing, standardizing, and scaling workforce knowledge. Skilled workers are retiring, and labor shortages are persisting. Outdated, paper-based documentation can no longer keep up.
Outliers are values that don’t “fit in” with the rest of the data. These extreme values are commonly considered a nuisance when we seek to summarize the data with our descriptive statistics.
Maybe you’re pulling reports from three different platforms, trying to reconcile numbers that don’t quite match. Maybe you’re manually copying and pasting from multiple spreadsheets, hoping you didn’t introduce any errors along the way.
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