About Us

Our Experience

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After 15 plus years in the industry, we decided to alter direction. Now, we share our passion by helping others. Our process is designed to help you build a medical device Quality Management System (QMS) that makes the most business sense for your company and product(s). Talk to us today about how we can support your growth, enable your continuous improvement, and put you on a solid track to ensure success and continued profit.

Our Approach

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Whether you are a start-up or established medical industry company, our service includes a comprehensive consult to help identify gaps and opportunities, a comprehensive report that includes a project plan with timelines and milestones, a cost analysis, and a schedule. We will then help you establish or refine your system quickly and smoothly. That’s how we ensure your success.

Why Us?

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We understand regulatory; we understand quality; we understand the global landscape and nuances. Whether you’re seeking a strategic alliance with the right partner or a special skillset or tool, call us today. Together we’ll create and refine your plan for success. We didn’t get there alone. And neither will you.