A FDA, CE Mark, ISO 9000 and HACCP management consulting and marketing consulting company, specializing in IVDD and MDD CE Mark Technical File Preparation, 510(k) preparation, ISO 9000 and Customized Quality Systems for GMP compliance, Design Control Programs, ISO/GMP Trainings, Strategic Planning and Management Training, Mock FDA Audits, ISO Gap Analysis Audits, FDA Troubleshooting and Clinical Trials, Strategic Planning and Management Training, Business Strategy & Development, Project Management, New Product/Market Evaluations, Competitive Environment Analyses, Business/Marketing Planning, and Strategic Partnering/Distribution Arrangements.