AI Augmented Systems Engineering for Regulated Medical Devices
Helping medical device teams translate clinical, technical, regulatory, and business needs into robust architectures, requirements, risk controls, and verification strategies.
Harness the power of AI within a disciplined systems engineering framework for your medical device development.
Creating Momentum for Medical Innovation to Address Unmet Human Health Needs. Powered by AI. Guided by Human Connection.
Consulting Services
Support across the product development lifecycle, from concept definition through design controls, integration, verification, and regulatory submission readiness.
System Architecture
Architecture, subsystem decomposition, interfaces, states/modes, trade studies, and connected-device system definition.
Requirements Engineering
User needs, system and subsystem requirements, interface requirements, acceptance criteria, and traceability structure.
Risk Management
ISO 14971-aligned hazard analysis, risk controls, risk traceability, and risk-informed verification planning.
Design Controls
Design input/output traceability, review readiness, DDF/DHF support, and remediation of documentation gaps.
Integration & Verification
System integration planning, characterization, verification strategy, test method definition, and objective evidence.
Standards Mapping
Practical mapping of IEC 60601, IEC 61010, IEC 62304, IEC 62366, ISO 14971, and cybersecurity expectations.
Medical Device Expertise
Specialized support for teams developing regulated devices that combine electronics, firmware, software, sensors, connectivity, and clinical workflows.
Connected Devices
BLE-enabled devices, mobile app interfaces, cloud-connected workflows, cybersecurity requirements, and device-to-software interfaces.
Diagnostic Systems
IVD systems, home-use devices, sample measurement workflows, data integrity, and single-use device constraints.
Therapy Systems
Energy-delivery platforms requiring disciplined architecture, controls, integration, and verification strategies.
Engagement Approach
A structured but practical process designed to quickly identify gaps, align stakeholders, and produce usable engineering outputs.
Assess
Review architecture, requirements, risks, interfaces, standards, traceability, and documentation maturity.
Structure
Define a systems engineering framework tailored to the product, team, and regulatory path.
Deliver
Produce development-ready or submission-supporting artifacts with rationale, traceability, and objective evidence.
Let’s Discuss Your Device Program
Whether you are defining a new product, remediating design controls, preparing for verification, or aligning a cross-functional team, Momenta MedTech can bring structure and technical clarity to your development process.
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