Medical Systems Consult

Medical Systems Consult provides engineering and regulatory compliance consulting services for medical device manufacturers. The firm handles the full lifecycle from initial strategy through FDA and EU Notified Body submissions, specializing in design history documentation and regulatory requirements for both premarket and postmarket phases.

The company's technical expertise spans MedTech, drug delivery devices, diagnostics, and digital therapeutics. Their capabilities include Software as a Medical Device (SaMD) development, embedded medical systems, mobile device integration, cloud/backend systems, AI/ML applications, and EHR/EMR integrations. They maintain expertise in quality system regulations including 21 CFR Part 820 and EU MDR 2017/745, as well as international standards such as ISO 14971 for risk management.

Medical Systems Consult works across multiple device categories including consumer health products, critical care equipment, patient monitoring systems, bio-sensors, wearables, infusion systems, point-of-care diagnostics, and prescribed digital therapeutics.

Medical Systems Consult is positioned for organizations that need specialized regulatory and engineering expertise for medical device development, particularly when navigating complex FDA or EU approval processes. Their focus on design history documentation and quality system compliance makes them relevant for manufacturers preparing submission packages.

Companies developing connected medical devices, SaMD applications, or digital therapeutics may benefit from their technical expertise in modern technologies combined with regulatory knowledge. Their experience spans the full device lifecycle including postmarket surveillance and project recovery scenarios.

Medical Systems Consult operates exclusively in the medical device sector, serving manufacturers across MedTech, drug delivery, diagnostics, and digital therapeutics verticals. Their services address the highly regulated nature of medical device development, ensuring compliance with FDA Quality System Regulation and EU MDR requirements.

The firm's healthcare focus extends to specialized device categories including critical care equipment, transplant systems, patient monitoring, bio-sensors, wearables, infusion devices, respiratory systems, point-of-care diagnostics, IVD systems, and prescribed digital therapeutics for disease management.

Medical device manufacturers developing regulated products requiring FDA 510(k), PMA, or EU MDR submissions. Companies creating Software as a Medical Device, connected devices with mobile or cloud components, or digital therapeutics that need comprehensive design controls and risk management documentation.