Artificial Intelligence Regulatory Compliance

FDA-Grade AI Compliance in Medical Device Software

Simplify change management and accelerate development across your AI lifecycle.

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.

Enable your developers to release software frequently and use open-source AI/ML packages.

Scale your machine learning models to real-world demands.

Book a demo

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).

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.

Built-in frameworks enforce best practices for coding, version control, and collaborative development.

Robust validation and verification processes ensure high quality.

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 (ML-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.

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.

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,