Heyer Regulatory Solutions



The expert source for global regulatory strategies.


Heyer Regulatory Solutions is the expert source for innovative strategies to get your medical device, combination product, or diagnostic to market and keep it there.  Whether you are a start up company new to the world of medical device regulation or an established company looking to outsource, Heyer Regulatory Solutions has the experience, knowledge, skills, and contacts to help you meet your global business goals.  


With Heyer Regulatory Solutions you get the advantages of:


  • 26 years of regulatory experience: at FDA, in industry, and working with a wide variety of medical device and diagnostics companies 


  • Global premarket strategies to optimize time to market in all target geographies


  • Follow through with smart postmarket surveillance and compliance programs


  • Attention to detail - the key to avoiding costly mistakes


  • Personal service tailored for your business


  • A commitment to excellence and integrity in all that we do






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