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| MBC & Associates is a full service Quality System and Regulatory Compliance consulting firm dedicated to the Life Sciences. We have over 19 years of experience working with start up companies to get FDA approval and large companies to improve quality, compliance, and production performance. We provide strategic planning, audit management, training, quality system support and many other advisory and hands-on services. |
Serving Medical Device & In-Vitro Diagnostics Companies
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Start-ups and R&D-Phase We'll help you navigate the complex journey from product concept to commercialization. Make sense of the regulations affecting your business >> |
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Established and Production-Phase We'll deliver improved performance, eliminate inefficiencies, and increase compliance. Make measurable improvements to your quality systems >> |
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Expert Guidance Through The Regulatory Maze MBC & Associates has real-world experience and a team of specialists that work together to deliver consistent results to our clients across the globe. Our model for success:
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Get FDA Approval Quick answers to your questions about the regulatory maze. Get Started >> |
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Get Measureable Improvements We'll show you how to improve performance, eliminate inefficiencies, and increase compliance. Get Started >> |
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Our Clients Are Talking Top Notch Results... "Outstanding Quality and Regulatory Professional. Melita consistently delivered top notch results and great feedback." - Gary Gilliam Dir. Business Excellence Medtronic Physio-Control Gifted at meeting Goals... "Melita is a talented professional who makes quick and correct decisions. Melita is gifted with the ability to differentiate between important and less important in a way that both goals and time lines are met. I’ve met dozens of persons in similar roles and no doubt Melita is one of the best that I've ever worked with." - Gilad Kigel Project Manager Sparta Systems |