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Consultant Profile
OPTIM Associates, Inc., employs former FDA and industry professionals specializing in U.S. and European medical device regulations. Our knowledge base encompasses products of all device classifications, including combination products.
Our executive team members each have a minimum 17 years success in FDA regulated medical device, pharmaceutical and healthcare industries: Quality Systems, Regulatory Compliance, Risk Management and Reliability. Our team members are experienced subject matter experts (SME) in research and development, design and process validation, manufacturing operations, calibration, analytical laboratories, product test laboratories and post-market surveillance systems / processes representing (micro)Biology, Radiology, Electrical, Mechanical, Software, Statistics, Technical Publications and Quality science disciplines.
OPTIM Associates proactively applies refined skills with best program and project management practices implementing practical cross-functional solutions addressing regulatory requirements and business demands. Responding to FDA Regulatory Actions--483, Warning Letter, Import Detention, Consent Decree--OPTIM Associates, institutes immediate corrective solutions as foundation for future robust and sustainable performance.
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