Experienced mountaineers will tell you that the one thing you can count on while climbing is change. It's the same in the global regulatory environment. One minute it's sunny and calm, the next a storm makes the going impossible. That's why you need an experienced guide to help plan your way to the top, and lead you through those changes.

I'm Dave Kern, the founder of K2 Regulatory Consulting. With 30 years of experience in the IVD medical device industry, I can help you chart the best path to your goals. My diverse professional background and experience in regulatory affairs makes me uniquely qualified to build a regulatory strategy that will position your company for success in an ever-changing global marketplace.

Let's get started.

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