Medical Systems Consult
Medical Systems CONSULT is a medical device expert company dedicated to helping clients accelerate their medical device development, ensure regulatory compliance, and improve safety and quality through innovative engineering, risk management, and regulatory strategies. They specialize in MedTech, drug delivery, diagnostics, and digital therapeutics, providing comprehensive services from initial strategy to project recovery, and supporting all regulatory pathways including FDA and EU Notified Body submissions.
Industries
Nr. of Employees
small (1-50)
Medical Systems Consult
Dracut, Massachusetts, United States, North America
Products
AI adverse-event analysis app
An AI application that queries adverse-event databases, performs NLP and semantic analysis, and generates summarized PDF reports highlighting trends and problem summaries.
AI automation and scheduling app
An automation app that schedules AI analysis tasks, manages execution cadence, and distributes results via email with optional attachments and activity logs.
Regulatory content assistant (submission drafting)
AI-assisted tool to extract information from predicate summaries and generate eSTAR-like submission content for FDA 510(k) preparation, with user review and editing capabilities.
Document ingestion and Q&A tool
A document chat tool that ingests PDFs, answers context-specific questions, displays responses, and saves Q&A as a Word document for reference.
AI adverse-event analysis app
An AI application that queries adverse-event databases, performs NLP and semantic analysis, and generates summarized PDF reports highlighting trends and problem summaries.
AI automation and scheduling app
An automation app that schedules AI analysis tasks, manages execution cadence, and distributes results via email with optional attachments and activity logs.
Regulatory content assistant (submission drafting)
AI-assisted tool to extract information from predicate summaries and generate eSTAR-like submission content for FDA 510(k) preparation, with user review and editing capabilities.
Document ingestion and Q&A tool
A document chat tool that ingests PDFs, answers context-specific questions, displays responses, and saves Q&A as a Word document for reference.
Services
Regulatory submission and strategy support
Regulatory pathway identification and preparation of submission dossiers for US and international markets including 510(k), PMA, De Novo, IDE, CE Mark, and other country registrations.
Quality management system implementation and audit support
QMS assessments, ISO 13485 implementation, mock audits, CAPA remediation planning, supplier audits, and training to achieve audit readiness.
Engineering and product development
End-to-end device design and development services including systems architecture, electrical and mechanical design, embedded firmware, software, verification and validation, and rapid prototyping.
Risk management and human factors services
Hazard analysis, FMEA, usability engineering, cybersecurity risk analysis, and development of risk management files aligned to international standards.
Postmarket surveillance and adverse-event analytics
Design and execution of postmarket surveillance programs, adverse event data collection and analysis, and preparation of vigilance and MDR reports.
Project management and staffing
Adaptive lean project management, managed engineering teams, and specialist placements for software, hardware, verification/validation, and QA roles.
Regulatory submission and strategy support
Regulatory pathway identification and preparation of submission dossiers for US and international markets including 510(k), PMA, De Novo, IDE, CE Mark, and other country registrations.
Quality management system implementation and audit support
QMS assessments, ISO 13485 implementation, mock audits, CAPA remediation planning, supplier audits, and training to achieve audit readiness.
Engineering and product development
End-to-end device design and development services including systems architecture, electrical and mechanical design, embedded firmware, software, verification and validation, and rapid prototyping.
Risk management and human factors services
Hazard analysis, FMEA, usability engineering, cybersecurity risk analysis, and development of risk management files aligned to international standards.
Postmarket surveillance and adverse-event analytics
Design and execution of postmarket surveillance programs, adverse event data collection and analysis, and preparation of vigilance and MDR reports.
Project management and staffing
Adaptive lean project management, managed engineering teams, and specialist placements for software, hardware, verification/validation, and QA roles.
Expertise Areas
- Regulatory compliance and submission strategy
- Quality management systems (ISO 13485) and audit readiness
- Embedded medical systems engineering
- Digital health and Software as a Medical Device (SaMD)
Key Technologies
- Embedded firmware and real-time systems
- Cloud backend and IoT infrastructure
- AI/ML (NLP, retrieval-augmented generation)
- Semantic vector search and document chunking