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OPTIM Associates provides Quality Management Systems, Risk Management, Dependability and Safety solutions for the Medical Device and Pharmaceutical industries. Regulatory compliant, value added and cost effective. Specifically tailored for seamless integration into Quality Systems, Business Processes and Documented Procedures. OPTIM performance solutions deliver targeted, integrated, robust, and sustainable results across the entire product / process life cycle:
- Targeted; enhance existing capabilities, achieve business objectives without adding manpower or reducing efficiencies.
- Integrated; clear and seamless linkages within existing business and quality systems.
- Robust; withstand natural variability, hold bottom line.
- Sustainable; stay proactive, meet operational goals, top line growth.
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- FDA Enforcement Actions: 483's, Warning Letters, Import Alerts/Detention, Concent Decree
- Device / Process Remediation: Corrections and Removals, Remediation Plans, Re-Design Process and Product
Specialties
- Risk Management: ISO 14971, Design / Process FMEA, Fault Tree, HazOP, HACCP, Usability and Human Factors Analysis
- Dependability: Reliability / Maintainability / Availability, Hardware and Software Reliability, Test Planning, Reliability Growth, Warranty and Service Analysis, Life Cycle Costing
- Safety: ISO 60601, Requirements Analysis, Design Evaluation, Process Safety Analysis
- Audits & Assessments: ISO 14971, ISO 9001, ISO 13485, Quality Systems, Design Controls, CAPA Effectiveness, Pre-QSIT FDA Inspections
- Incident Investigation: Field Complaints / Failures, Root Cause Determination, Process Non-Conformances
- FDA Regulations: Devices, Pharma, ERES, Quality Systems, Design Controls, Product / Process Validation, Corrections and Removals, Medical Device Reporting
- 21CFR: Parts 803, 820, 806, 211, 210, and 11
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