SaMD, AI and Algorithms
Stand-alone software and validated models for real clinical use
MedTechWare designs SaMD products and algorithms that turn data into decisions. We align intended use, build the software, and produce the evidence needed for regulatory review while protecting patient privacy and safety.
From intent to evidence
Successful SaMD starts with a clear claim and ends with reliable evidence. MedTechWare helps you define intended use, user groups, and clinical context, then turns those inputs into software and models that perform in the real world. We build pipelines that keep data organized, trace experiments, and reproduce results. We focus on model clarity, not just accuracy, so clinicians can trust what they see. Our process covers data curation, feature engineering, training, and verification against predefined acceptance criteria. We prepare the documentation sets that reviewers expect and we plan for monitoring after release. The result is a product that works, is understandable, and is ready to scale.
Human-Centered design for AI and SaMD
User Research
Field studies with clinicians and operators to map real workflows
PCCP Planning
Predetermined Change Control Plans for safe model and software updates
Explainability
Model cards, confidence cues, and clear rationale in the UI
Cybersecurity
Threat modeling, SBOM creation, secure deployment, and monitoring
Risk Management
Controls mapped to intended use and documented traceability
Model Engineering
Field studies with clinicians and operators to map real workflows
Human Factors
Formative and summative testing with acceptance criteria
Software and UI
Back-end, APIs, and clinician friendly interfaces built together
Security By Design
Connected products succeed when the entire path is solid. MedTechWare builds the pieces that turn raw signals into decisions. Devices stream data to secure APIs. Pipelines validate and store it. Web portals and mobile apps present clear views for clinicians, operators, and patients. We design identity and access with least privilege. We implement observability so teams can find issues before users do. We plan for performance, outages, and growth from the first sprint. Whether you are launching a new SaMD platform or modernizing an existing stack, our goal is simple. Deliver a system that feels fast, stays reliable, and protects sensitive data.
Dedicated Expertise
Tech Stack
Security from day one
Identity, MFA, and least privilege roles
Logging, metrics, and alerting with retention policies
Pen testing support and remediation backlog
Encryption in transit and at rest
SBOM for services and dependency scanning
Playbooks for incident response and postmarket monitoring
Ensuring Excellence in Embedded Software Development
At MedTech Ware, we prioritize safety-critical coding practices. Our commitment to MISRA compliance and rigorous static analysis ensures reliable and secure software.
Safety-Critical
We adhere to industry standards to deliver safe and effective embedded solutions.
Quality Assurance
Our static analysis techniques identify potential issues before they become problems.
How we work
1. Discover
Align workflows, privacy needs, and success metrics
What you get
Reliability
Reliable data flow from device to cloud to UI
Clarity
Interfaces that users understand on the first try
Velocity
Fewer handoffs and faster releases
Scalability
A platform that can scale without surprises