Support across the product development lifecycle, from concept definition through design controls, integration, verification, and regulatory submission readiness.
Development of product architecture, subsystem decomposition, interface definition, interface control, and technical trade studies for complex electromechanical, software, firmware, and connected medical devices.
Creation, refinement, and remediation of user needs, system requirements, subsystem requirements, interface requirements, and verification-ready acceptance criteria.
ISO 14971-aligned hazard analysis, risk controls, traceability, risk-benefit documentation, and integration of risk controls into design inputs and verification plans.
Support for design input/output traceability, design reviews, DDF readiness, verification planning, and remediation of gaps in regulated development documentation.
Planning for system integration, characterization, design verification, traceability matrices, test method definition, and objective evidence.
Practical mapping of applicable standards such as IEC 60601, IEC 61010, IEC 62304, IEC 62366, ISO 14971, and cybersecurity expectations into actionable engineering deliverables.
Momenta MedTech uses AI-enabled workflows to accelerate analysis, traceability, requirements definition and refinement, risk-control mapping, and documentation structure — while maintaining expert human judgment for regulated medical device development.
Specialized support for teams developing Class II & Class III devices that combine electronics, firmware, software, sensors, connectivity, and clinical workflows.
BLE-enabled devices, mobile app interfaces, cloud-connected workflows, cybersecurity requirements, and device-to-software interfaces.
IVD systems, home-use devices, sample measurement workflows, data integrity, and single-use device constraints.
Energy-delivery platforms requiring disciplined system design.
Design controls, risk management, usability, software lifecycle, verification, validation, and submission-support documentation.
A structured but practical process designed to quickly identify gaps, align stakeholders, and produce usable engineering outputs.
Review architecture, requirements, risks, interfaces, standards, traceability, and current documentation gaps.
Define a clear systems engineering framework tailored to the product, team maturity, and regulatory path.
Create or refine requirements, architectures, risk controls, interface definitions, and verification strategies.
Facilitate cross-functional reviews with engineering, clinical, regulatory, quality, cybersecurity, and program teams.
Provide submission-ready or development-ready artifacts with clear rationale, traceability, and objective evidence.
Whether you are defining a new product, remediating design controls, preparing for verification, or aligning a cross-functional team, Momenta MedTech can help bring structure and technical clarity to your development process.
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