MEDICAL DEVICE REGULATORY & CLINICAL CONSULTING
Learn how we can help your business
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.
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Areas of expertise include:
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510(k) and PMA submissions
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IDEs, including Early Feasibility Studies
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EU MDD/AIMDD/MDR Documentation, including Technical Files and Design Dossiers
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Quality System Requirements
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Regulatory support for product development
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Clinical Evaluation Reports
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FDA and Notified Body audit preparedness and support
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contact
NEW SOUTH REGULATORY
223 Coventry Road
Decatur, GA 30030 USA
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Tel 404.542.5854
Please let us know how we can help your business: