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.
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
contact
NEW SOUTH REGULATORY
223 Coventry Road
Decatur, GA 30030 USA
Tel 404.542.5854
Please let us know how we can help your business: