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Mountain Lake

MEDICAL DEVICE REGULATORY & CLINICAL CONSULTING

Learn how we can help your business

About

About

New South Regulatory offers medical device regulatory and clinical consulting to start-up companies and established manufacturers of all sizes.  

Wendy Perreault (Owner/Principal) has over 20 years of experience in the industry, working with all classes of products in the US and abroad in many fields of medicine. 

      Areas of expertise include:

  • 510(k) and PMA submissions

  • IDEs, including Early Feasibility Studies

  • EU MDD/AIMDD/MDR Documentation, including Technical Files and Design Dossiers

  • Quality System Requirements

  • Regulatory support for product development

  • Clinical Evaluation Reports

  • FDA and Notified Body audit preparedness and support

Contact

contact

NEW SOUTH REGULATORY

223 Coventry Road

Decatur, GA 30030 USA

Tel 404.542.5854

Email wendyperreault@newsouthregulatory.com

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