OPTIM Associates, Inc

OPTIM Associates, Inc. | UT & WI | (847) 707-7560

Quality, Safety and Effectiveness Performance Solutions-Medical Devices

Regulatory and Performance Solutions for Safe and Robust Medical Devices

Auditing

As your Quality System naturally evolves, accurate and meaningful Audits provide direct feedback on the compliance health, direction and pace of your evolution.  OPTIM Associates delivers professional and high integrity audits including   Baseline, Verification, Internal, Pre-Approval, Supplier and Quality Systems audits.   

Quality Systems Development & Optimization

Your Quality System (QS) is the fundamental entry requirement for medical device success.   A dynamic system growing and evolving along side business objectives.

Remediation: Quality Systems & Products

OPTIM Associates recognizes that “time is money” and regulatory enforcement has a major impact on both.  Quick and accurate identification and modification of key decisions along with changing organizational behaviors to meet regulatory compliance expectations is crucial to efficient, effective AND sustainable Quality System and Product Remediation. 

Medical Device Start Ups

OPTIM Associates understands what it takes to get a device approved by FDA and/or EU and bring your product to market. We completely understand how many milestones and deliverables need to be accomplished sometimes with limited funding / financing. 

Training

Adequately trained personnel are the heart-beat of your organization.  OPTIM Associates delivers training on US Regulations, OUS Regulations (EU-MDR), International Standards and more using Universal Instructional Design (UID) Principles and Verifies Training Effectiveness to ensure comprehension and continued excellence. 

Expert Witness

During the life-cycle of your products, you may have needs for a device expert witness to attest to Safety and Efficacy. OPTIM Associates has qualified professionals trained in regulations with skills navigating the legal process. 

Tobacco & E-Cigarettes

 OPTIM Associates understands what it takes to get a device approved by FDA and/or EU and bring your product to market. We completely understand how many milestones and deliverables need to be accomplished sometimes with limited funding / financing. 

Interim Staffing & Resourcing

 OPTIM Associates is uniquely capable and qualified in providing experienced and respected professionals to fill unexpected vacancies or immediate remediation demands. Our quality system professionals draw on years of experience and specialized expertise / skills to ensure compliance and achievement of on-going business objectives. 

Specific Programs: Risk Management, Usability / Human Factors / Software Life Cycle

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