Provide the efficient, effective and sustainable professional consulting solutions to continually enhance product quality, patient safety and product effectiveness while maintaining compliance with governmental regulations, standards and best practices that exceed client expectations.
The mission of OPTIM Associates is to provide effective and efficient solutions—with a focus on scalabiity and sustainability—and deliver highest value and quality for the Medical Device Industry. We actively listen for immediate and underlying causes to offer solutions based on best practices across multiple disciplines. We ensure our clients receive innovative solutions that address Regulatory Compliance, Organizational Change and Financial Results.
Our company vision is a relentless infusion of innovative solutions in support of robust products and quality systems in harmony with Strategic Financial Objectives, Regulatory Expectations and Organizational Change. Our vision focuses decision-making at all (organizational) levels to ensure the three (3) fundamental pillars are aligned and in-synch: 1) Business Strategies, 2) Implementation Tactics and 3) on-going Organizational Change.
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.
All OPTIM Associates senior consultants have a minimum of 15 years experience within the Medical Device Industry or the FDA and are highly valued for their regulatory knowledge and business implementation experience. Our team has compliance and implementation proficiency on a wide range of technical topics, including all areas of 21CFR820, Quality System Regulation—Management Controls, Design Controls, Risk Management, Reliability, Document Controls, Purchasing Controls, Production & Process Controls, IMT&E, Process Validations, Non-Conforming Product, CAPA, Labeling and Packaging Controls, Handling, Storage, Distribution, and Installation, Servicing and Statistical Techniques.
OPTIM Associates proficiency extends to 21CFR803 (Medical Device Reporting), 21CFR806 (Corrections and Removals), 21CFR11 (Electronic Records / Electronic Signatures), 21CFR1100/1140/1143 (Deeming Tobacco Regulation), the EU Medical Device Regulation and other OUS Regulations.
Our collective expertise extends into relevant international standards, GHTF guidelines and best practices to ensure you are receiving comprehensive and highest quality solutions.