MedicalDevice_TLB_8.25
Products by Optim Associates, Inc.
  • 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
  • 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
  • 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
White Papers by Optim Associates, Inc.
  • OPTIM REPORT #4 - LOGICAL FALLACIES By

    In our professional and personal conversations, not only is clear communication necessary, but it is equally important to be able to recognize questionable statements and arguments. We have to be constantly vigilant about how we communicate and not fall into the traps of using Logical... Read more