The Know-How to Know How
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Medical Engineering Consultants conducts compliance and regulatory rules issues investigations and identifies inefficiencies in order to help create peace of mind and increase profitability. For your medical device or pharmaceutical company, that translates to critical support for governing everything from supplier quality and manufacturing distribution to handling complaints — all while coordinating the day-to-day adherence to hundreds of FDA and international regulations and processes. By combining mechanical expertise with medical device knowledge, you can more efficiently validate processes, uncover and isolate compliance system gaps between current and FDA expected requirements, and reverse shortcomings or holes that are causing your processes and systems to function below standard.
Regulatory approval and compliance checks come with the territory. However, you no longer have to struggle to understand or keep up with them. MEC’s mission is to bury the burdens, barriers and breakdowns they create throughout your company via worry-free compliant systems and processes that sustain ongoing improvement. This creates a clearer roadmap for your future based on driving operational excellence and continuous improvement through daily metrics, tools and systems applied to input, output, cost and time.
Handling FDA 510(K) applications for medical devices is where Medical Engineering Consultants excels. You can now easily know what you need, when you need it, what the current compliance requirements or regulations are, and whether you’re on track to cost-effectively meet them by your deadline. Just ask MEC.