Micron Solutions has once again passed its ISO 13485 audit with zero findings. This achievement reflects our continued dedication to quality, regulatory excellence, and building trust with our partners in the medical device industry. 

Consistency in Excellence 

For the team at Micron, quality is a standard we uphold every day, which is why passing our ISO 13485 audit with no findings (again) is something we’re proud to share. 

Audits of this caliber are a comprehensive review of everything from documentation and traceability to training and risk management. To come through with zero findings is more than a “good result.” It’s a clear signal that our systems and people are aligned, disciplined, and committed to excellence. 

What Makes Passing ISO 13485 “With No Findings” Different 

Many companies can meet baseline requirements. Passing without a single finding, however, means that auditors saw no gaps, no weak points, and no corrections needed. It’s a rare outcome, and one that highlights not only compliance but consistency at every level of our operations. 

What Is ISO 13485? 

ISO 13485 is the internationally recognized quality management system standard specifically for medical devices. 

It ensures manufacturers like Micron Solutions have the right systems in place to deliver safe, consistent, and compliant products. From design controls to traceability, ISO 13485 provides the framework that keeps processes reliable and minimizes risk. 

For customers, this means confidence that every component we produce is supported by a proven system. For regulators, it's an assurance in our commitment to compliance and excellence. 

What This Means for Micron 

Audits are never simple. They take time, focus, and a lot of preparation. That’s why the outcome matters so much to us. When the results come back clean, it tells us the effort we put in every day is working. 

“Our team doesn’t treat quality as a once-a-year event,” said Bill Laursen, CEO of Micron Solutions. “The [ISO 13485] audit just confirms what we diligently do every day. Our team cares deeply about getting it right for our customers and for patients.” 

The Payoff of a Strong Quality Culture 

This audit result affirms the value of our ongoing investments in training, process control, and continuous improvement. It reinforces the trust our partners place in us to deliver critical products (from orthopedic implants to advanced sensor assemblies) that meet the highest possible standards. 

Looking Ahead 

As we look forward, this clean audit is both a milestone and a motivator. It confirms that Micron is not just keeping pace with industry standards, we’re actively setting the tone for what excellence in medical device manufacturing looks like. 

For our customers, it’s reassurance. For our team, it’s a moment of pride. And for Micron as a whole, it’s one more step toward shaping the future of medical device manufacturing. 

Ready to work with a medical device manufacturer that puts quality at the forefront? Contact us today.