Products by Optim Associates, Inc.

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  • Auditing

    Baseline Audits. Baseline Audits establish the “base-line” regulatory compliance health evaluation of the Quality System and documents any associated Quality System gaps. Verification Audits. Verification Audits confirm progress against Baseline Audit findings or are used to periodically... Read More
  • OPTIM Associates Services

    Auditing Quality Systems Development & Optimization Remediation: Quality Systems & Products Medical Device Start Ups Training Expert Witness Tobacco & E-Cigarettes Interim Staffing & Resourcing Risk Management Design Control Usability / Human Factors Software Life Cycle... Read More
  • Quality Systems Development / Optimization

    QMS Development: Your Quality System (QS) is the fundamental entry requirement for medical device success. As such your QS needs to be treated as an investment and not a cost-center. Your QS needs to be scalable to your current business demands and continually grow along-side your evolving... Read More
  • Remediation: Quality Systems & Products

    QS Remediation Defined: Quality Systems Remediation is the process of recognizing change is necessary, identifying systemic issues, performing Root Cause Analysis, creating a plan—or plans—for immediate correction and future prevention of the resurfacing of the issues and then execute to the... Read More
  • Specific Programs

    Risk Management: A compliant Risk Management process comes in many forms. The key is to tailor your Risk Management program to align with your company needs including company size, budgets, and organizational maturity. Finding the proper balance for your company, your Quality Management System... Read More
  • Training

    Overview: Often times, personnel are not trained to adequately perform their assigned responsibilities or are not made aware of device defects which may occur from the improper performance of their specific jobs. OPTIM Associates recognizes and uses proven Universal Instructional Design (UID)... Read More

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