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About Medical Systems Consult

Medical Systems Consult is a systems engineering and product development consulting company specializing in electromechanical medical devices, IVD automation software, and digital health solutions. At Medical Systems Consult, our working model is based on a systems thinking approach with emphasis on collaborations between cross-functional business stakeholders and subject matter experts, and driven by international state of the art standards and best practices - the results are High Quality, Effective & Innovative Solutions, On-Time and On-Budget. Medical Systems Consult can partner with you to bridge any gaps in technical staffing, multi-disciplinary product development and testing, and regulatory compliance consulting. We have established a rich network of subject matter experts & associates that have a unique skill set, from product design, complex system engineering, human factors and mechanical engineering through full-stack software and interconnectivity for IOT to market access and total product life cycle management. Our associates network includes experts in combination products, connected health solutions, clinical validation, usability/human factors, former regulatory agency auditors, application specific post-market, expert review panels, safety conformity assessments and certifications, and many other fields, to help get your products to market quicker. Our specialties include: - Software Development Life Cycles for Safety-Critical Class II and III Medical Devices, meeting IEC 62304 and ISO 14971 requirements, aligning SOPs and generating complete DHF artifacts for compliance coverage. - Risk Management per ISO14971, incorporating software validation and traceability, and aligning with current FDA guidance on current topics such as cybersecurity risk management, human factors aspects, and Software as a Medical Device (SaMD) design principles. - Quality Management Systems meeting ISO 1385, 21 CFR 820 & 21 CFR 803, and Part 11.

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