Consultants Directory on Medical Device Link Index

OPTIM Associates Inc.

P.O. Box 1006
Lake Villa, IL 60046 USA
Tel: 877/332-7475
Fax: 847/265-0870

Contact: Ken Schmidt
Year Established: 1998

Web: http://www.optimcorp.com
E-mail: information@optimcorp.com

Description:
Optim Associates delivers reliability, safety, and risk-management solutions to the medical device and pharmaceutical industries. Specialized expertise includes risk management (ISO 14971), robust design techniques, life-cycle design for reliability (DFR), project management, incident investigation, root-cause analysis, total productive maintenance, and reliability program development. Warranty policies, end-of-life predictions, FDA design controls, protocol development, design and process validation, product surveillance, statistical trending, FMEA, and risk analysis are among the company's other capabilities.

Categories this company is listed under in the Consultants Directory on Medical Device Link:

• Audits/Inspections (38 companies)
• Failure Analysis (14 companies)
• Good Manufacturing Practices/Compliance (51 companies)
• Insurance/Risk Management (2 companies)
• Process Validation (32 companies)
• Product Development (44 companies)
• Project Management (25 companies)
• Quality Assurance (44 companies)
• Quality Management (19 companies)
• Quality Systems Certification (13 companies)
• Reliability Engineering (6 companies)
• Safety (13 companies)
• Statistical Analysis (9 companies)