Artificial Intelligence Regulatory Compliance
FDA-Grade AI Compliance in Medical Device Software
Automate compliance work, understand change impact instantly, and release your AI/ML products faster, without sacrificing quality.
For many teams, internal processes and tools are the main limiting factors to releasing more frequently. Implementing AI and compliance requires medical device software teams to overcome this challenge.
AI Regulatory Compliance
To use AI/ML in medical devices, medical device software teams need to release faster while staying compliant.
Advanced AI and ML models can improve the accuracy and reliability of medical devices. But how do you integrate your AI/ML model into your existing software system and design controls? Thanks to the recent PCCP guidance, medical device software teams are no longer constrained by the FDA when it comes to AI/ML.
.png)
How Heartflow Reuses Components to Build AI SaMD Faster
Heartflow, a SaMD company serving 250,000 patients annually, needed to speed up development and release their AI-based software more frequently. By adopting a system of systems approach, Heartflow transformed their monolithic architecture into a modular, microservice-based system within 10 weeks. Ketryx facilitated the migration of thousands of artifacts, streamlining their architecture and enabling efficient code reuse, reducing complexity, and accelerating release cycles.
Enable your developers to work in their preferred tools, automate compliance work with AI, and release AI/ML software more frequently.
Scale your machine learning models to real-world demands, without scaling
your documentation burden.
Book a demo
your documentation burden.
Use your preferred AI/ML tools
Rapidly accelerate AI compliance in software development and deployment, while monitoring model drift
Enable your PCCP with control of AI/ML subsystems so you can get to market faster
Download a free PCCP template
Attract and retain machine learning specialists, who can work in their preferred tools.
Connect model drift analysis and ML testing frameworks and leverage them as evidence against your requirements.
Automatically create traceability between requirements in Jira and tests in Git (or another code repository).
Use AI Agents to draft requirements, test cases, and risk controls, so your team spends less time on documentation and more time building.
Enforcement
Stay compliant with your PCCP and release faster
Keep your machine learning model compliant with relevant FDA and MDR regulatory requirements and standards. Ensure the ethical, responsible, and effective development and deployment of machine learning models in medical device software.
Explore enforcement
Built-in release gates ensure that your model has been validated before every release.
Transform data into specifications and leverage the specification approval process.
Transform data into specifications and leverage the specification approval process.
Robust validation and verification processes ensure high quality.
Agents run quality reviews, flag gaps in test coverage, and surface compliance issues before they become audit findings, with human review and Part 11-compliant approval on every action
Risk Management
Reduce the complexity of risk control and validation in AI systems
FDA guidance requires that any changes made to AI systems and subsystems (AI-DSF) go through rigorous testing, since these changes have cascading impacts.
Learn more about risk controls in AI/ML
Enforce validation techniques to assess the performance of your machine learning model.
Ensure models perform well on new data through automated tests in your CI/CD pipeline.
Continuously monitor the performance and risks of your model in real time so you can improve the model based on new data and user interactions.
Use a system of systems architecture to support ML-specific risk assessment
AI Change Impact analyzes how proposed changes affect downstream requirements, risks, and tests, delivering concrete recommendations in hours,
not weeks.
not weeks.
Traceability
Establish traceability for DataOps and MLOps
Enable state-of-the-art AI solutions while all work is documented automatically.
Explore traceability
Automatically document your model development process as you build it.
Maintain traceability and visibility with an always up-to-date trace matrix.
Maintain a history of how raw data is pre-processed for model training and validation.
Connect to DataOps tooling to ensure traceability between model requirements and risks.
When a design input changes, Ketryx automatically flags impacted downstream items, requirements, test cases, and risks, so nothing falls through the cracks.
AI Governance
Innovate and scale faster without sacrificing quality though better AI governance
Built-in enforcement gives your AI Governance Committee or CoE transparency and control.
Watch AI/ML webinar
Release controls gate release until all approvers have signed.
Part 11-compliant signatures ensure approvals follow QMS procedures.
AI Agents run on schedule or on demand, and email findings with recommended redlines that your team can accept, edit, or reject.
Every AI action is verifiable. Ketryx tracks all work, so your team can trust the output and regulators
can audit it.
can audit it.
.svg)