Saving money in the long run
On an average $24M to $75M USD spent on regulatory activities by medical device companies, let's plan in advance to ensure success.
Understanding regulatory needs at research phase
From an initial stage it's important to be aware of regulatory challenges, non-compliance costs medical device startups millions of dollars per year. Let's help you prevent that.
Helping understand FDA requirements
510(k)s, PMAs, QSR needs...
We help you understand all regulatory jargons!
Mechanical Engineer, Mathematician and an RAQA enthusiast passionate about developing innovative medical technologies.
Serial Entrepreneur, Biotechnology Engineer, Regulatory Affairs Professional with RAPS certifications in medical devices and drugs.
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In case of any questions please...