Charmaine Sutton B.S.
Regulatory, Reimbursement and Clinical Affairs Consultants

As a Partner in the Tamarack Group, Ms Sutton has developed CloSys’ regulatory strategy, directed the company’s pre-IDE regulatory compliance activities and Quality System development and has been CloSys’ representative to the FDA on several occasions. She continues to work as an advisor to the clinical group and will prepare and defend the regulatory submission. Ms Sutton is Regulatory Affairs Certified (RAC) with the Regulatory Affairs Professional Society and has been granted a Blackbelt Quality Engineering Statistics Certificate from the American Society for Quality. The Tamarack Group has been providing consulting services to medium, small and start-up medical product developers and manufacturers in the areas of US Food and Drug Administration (FDA) regulations and European Union medical product directives for 20 years. She also designs and analyzes quality systems for FDA/QSR and ISO compliance and assists the Company with post-market compliance matters.

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