Trained as a clinical microbiologist and worked in clinical laboratories for approximately 10 years.  Founded MDC Associates in 1988.  MDC is a consulting company specializing in providing regulatory, market research, and technical support services to companies in the in-vitro diagnostic industry.  The company has grown consistently over the last 30 years, conducting many clinical trials to generate the required data for FDA 510k clearance or PMA approval.  MDC has obtained FDA clearance for a variety of  in-vitro diagnostic products including products for MRSA, HSV, C. difficile as wells as products for  pregnancy tests, ovulation tests, glucose, cholesterol, nitrite in urine, drugs of abuse, HSV, HIV, and other infectious disease assays.

In-depth understanding of FDA, OSHA, and CLIA regulations.  Extensive experience developing study protocols, managing clinical trials, and preparing pre-market submissions.  Successful regulatory affairs management experience in the medical device and biotechnology industries.   

Strong industry knowledge of the in-vitro diagnostic market with emphasis on over-the-counter and point-of-care diagnostics.  

Trained as a clinical microbiologist and worked in clinical laboratories for approximately ten years.  Founded MDC Associates in 1988.  MDC is a consulting company that provides regulatory, market research, and technical support services to companies in the in-vitro diagnostic industry.  The company has grown consistently over the last 30 years, conducting many clinical trials to generate the required data for FDA 510k clearance or PMA approval.  MDC has obtained FDA clearance for a variety of in-vitro diagnostic products, including products for MRSA, HSV, and C. difficile, as well as products for pregnancy tests, ovulation tests, glucose, cholesterol, nitrite in urine, drugs of abuse, HSV, HIV, and other infectious disease assays.    

In-depth understanding of FDA, OSHA, and CLIA regulations.  Extensive experience developing study protocols, managing clinical trials, and preparing pre-market submissions.  Successful regulatory affairs management experience in the medical device and biotechnology industries.   

Strong industry knowledge of the in-vitro diagnostic market with emphasis on over-the-counter and point-of-care diagnostics.