REDEDGE CONSULTING

RedEdge Consulting is committed to helping clients find the most cost-effective method for achieving quality goals and regulatory compliance. By working closely with my clients, I can design, implement, and evaluate the systems and documentation necessary to meet U.S. FDA Quality System Regulation, ISO standards, European Medical Device Directives, and Canadian Medical Device Regulations... RedEdge Consulting provides strategic planning for new product introductions and expert planning, management, and preparation of regulatory submissions. I can offer an in-depth knowledge of FDA medical device regulations and policies. I can assist both small and large companies in meeting these regulations and requirements... RedEdge Consulting provides compliance solutions to meet all aspects of CDRH/FDA requirements and ISO quality systems. Capabilities include development of regulatory strategies, preparation of clinical trial documents (NSR and IDE submissions),