MEDICAL DEVICE REGULATORY & CLINICAL CONSULTING

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. 

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      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

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