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.
Principle: Kenneth B. Schmidt, MS
Senior executive with over 19 years effective leadership and consulting success in FDA regulated medical device, pharmaceutical and healthcare industries: Quality Systems, Regulatory Compliance, Risk Management and Reliability. Experienced subject matter expert (SME) in research and development, risk management, design and process validation, manufacturing operations, calibration, analytical laboratories, product test laboratories and post-market surveillance systems / processes. Demonstrated ability to implement and lead effective cross-functional solutions to meet regulatory requirements and critical deadlines proactively and in response to FDA Regulatory Actions: 483’s, Warning Letters, Consent Decree, and Import Detentions.
CERTIFIED RELIABILITY ENGINEER (CRE), American Society for Quality, Milwaukee, Wisconsin (Expired Certification #03525).
CERTIFIED QUALITY AUDITOR (CQA), American Society for Quality, Milwaukee, Wisconsin (Expired Certification #18717).
M.S. ENGINEERING MGMNT (Operations Research), Wichita State University, Wichita, Kansas.
B.A. MATHEMATICS (Physics), Bethel College, North Newton, Kansas.
AAMI – Association for the Advancement of Medical Instrumentation Member #411520
ASQ – American Society for Quality (ASQ), Senior Member Member #00974463
IEEE – Institute of Electrical and Electronic Engineers Member #40080863
RAPS – Regulatory Affairs Professionals Society Member #09238147
ISPE – The Society for Life Science Professionals Member #243977