About Optim Associates, Inc.
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.