OPTIM Associates is a Medical Device consulting company specializing in Quality Systems design, development, execution and remediation for newly developed products as well as existing fielded products. Our specialty runs the entire spectrum from Start-Up QS & 510(k) to QS Remediation assistance due to FDA enforcement actions.
Our team—in addition to QS Development—has extensive experience developing strategies and implementation tactics to address compliance gaps from FDA enforcement actions: 483s, Warning Letters, Consent Decrees and Import Detentions. We have a proven process to identify gaps, evaluate best possible solutions, close the gaps and guide you through execution.
OPTIM Associates is comprised of a team of top-tier respected professionals with a full range of expertise to meet your varied needs—Regulatory Experts, Compliance Experts, Auditors, Technical SME’s, Trainers, Project Managers, Program Managers, Medical and Legal Experts.
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
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
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
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
