Who We Are
Meet Our Team
Our Commitment
We are a specialized Medical Device Quality Assurance & Regulatory Affairs consulting firm supporting manufacturers across the full product lifecycle - from concept to commercialization and post-market compliance.
Why Choose Us
L. Thompson & Associates is a consulting firm based in Seattle, WA, with a team of 15 skilled professionals. They specialize in business strategy and operational efficiency, helping clients streamline processes and boost profitability.
100% Approval Rate
100% approval track record with regulatory authorities and Notified Bodies across all client deliverables.
Effective and Predictable
Efficient execution, predictable timelines, and uncompromising quality from concept to market approval
Medical Device Focus
Exclusively focused on the medical device industry.
Tailor Made Solutions
We do not serve boilerplate templates. We believe in finding the best fit for you.
Real Time Industry Exposure
Consultants are seasoned professionals with hands-on experience at medical device manufacturing
Global
Expertise
Expertise across global markets, including the United States, European Union, United Kingdom, and India.
Our Services
Regulatory Services
Optimus Compliance provides end-to-end regulatory support to help medical device and digital health companies achieve timely and compliant market access across global regions.
We work closely with your product and engineering teams to ensure regulatory expectations are embedded early, reducing review cycles, preventing costly rework, and enabling a smooth path from development to approval
Clinical Evaluation
We provide comprehensive clinical evaluation support, including strategy development, literature review, equivalence analysis, and CER preparation, ensuring compliance with EU MDR and global regulatory requirements.
Post-Market Surveillance
We design and implement robust Post-Market Surveillance and Post-Market Clinical Follow-up frameworks that enable continuous regulatory compliance, proactive risk monitoring, and ongoing clinical evidence generation
Quality Management
We build and maintain scalable, audit-ready Quality Management Systems that ensure compliance with global medical device standards and regulations such as ISO 13485, 21 CFR Part 820, IEC 62304, and MDSAP. We supporting efficient product development and sustained market access.
Audits
Auditing solutions include certified auditors performing risk-based internal audits, external audit preparation and support, and supplier audits to ensure ongoing compliance.
Usability/ Human Factor Engineering
We develop usability engineering strategy with a focus on regulatory alignment and use-related risk control, supported by the preparation of clear, compliant plans and reports in accordance with IEC 62366 and global regulatory expectations.
Technical Documentation
End-to-end preparation and maintenance of EU MDR technical documentation ensuring compliant and comprehensive submissions.
Founder
ANITHA JOSE
Anitha is a seasoned medical device Quality Assurance and Regulatory Affairs professional with nearly a decade of experience in the medical device industry.
With a strong background in product-based organizations and leading regulatory programs, she believes that compliance doesn’t have to slow innovation - it should enable growth, expand market access, and amplify impact on public health.
Over the years she has consulted for organizations such as:
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Philips
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Varex Imaging
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Dornier MedTech
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Circa Scientific
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Acme Medical
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AxioMed Inc.
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LESspine Inc.
10
Years of Expertise
Our Partners
Client Stories
We are a small company and needed someone who was knowledgeable and flexible. Optimus Compliance with a strong knowledge of ISO 13485 has helped us navigate the regulatory requirements with clarity.
James. H, Q Magnets
Optimus Compliance has supported Hyfe in establishing their QMS, the support provided by them was crucial for Hyfe to achieve their QMS goals. Their expertise in supporting the development of processes and translating regulatory requirements into clear, well understood documentation has been so helpful for Hyfe to achieve their targets on time!
Nathan Morrison, Hyfe Inc.
We collaborated with Optimus Compliance on part of our Technical Documentation, including Clinical Evaluation, Risk Management, and Usability Evaluation.
Anitha was always quick to respond and provided clear answers whenever we had questions. Her knowledge of the MDR requirements and understanding of the regulatory process helped us move forward with confidence in our documentation.
We really appreciated their support, and if we need a consultant for a future project, we would not hesitate to work with Optimus Compliance again.
Caroline Salemi, KIMSMED
