OPTIM Associates, Inc. is an independent consulting company providing litigation support for FDA regulated Medical Device and Pharmaceutical Manufacturing industries. Our regulatory knowledge and service areas are 21CFR Parts 820 and 803 regarding Quality Systems, Product Development, and Reportable Events—Malfunctions, Serious Injury, and Death. Specific technical expertise offerings: Risk Analysis, Risk Mitigation, Risk Remediation, Product Safety, Product Reliability, Incident Investigation and Root-Cause determination, Product and process failure prediction, and Design and Manufacturing controls.
