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Free Webinars

# Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices

July 16, 2024

60

minutes

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Understanding PCCP in a CICD Environment

Overview of Predetermined Change Control Plans (PCCP)

IEC 62304 and Software Lifecycle Management

Challenges in AI Software Development

Metrics and Validation in PCCP

Steps to Validate AI Systems

Model Validation and Acceptance Criteria

Integrating PCCP and CICD at Scale

Designing Systems for Regulatory Compliance

Challenges in Implementing PCCP

Navigating Ketryx

Ensuring Traceability and Risk Management

Understanding Product Architecture

Project Milestones Overview

Exploring System Traceability

Reviewing System Architecture

Finalizing the Release Approval

Risk Management Insights

Strategies for Rapid Change

AI Program Governance Framework

Closing Remarks and Invitation for Engagement

The FDA's Predetermined Change Control Plan (PCCP) allows medical manufacturers to update their device without repeated approvals. With this regulatory strategy, top medical device companies are incorporating agile methodologies into their work, including Continuous Integration and Continuous Delivery (CI/CD), so they can bring products to market faster while still ensuring safety and regulatory compliance.

#### What you'll learn

To help you start using CI/CD and PCCPs for your AI/ML-enabled products, this webinar will examine:

- Practical and systematic approaches to designing, constructing, and validating a successful PCCP with examples of model creation, data training, bias assessment, testing, and best-in-class infrastructure
- Processes for post-market ML software releases that enable continuous validation in production including ingesting real-world data, modification protocols, and metrics for ML models
- Strategies for implementing CI/CD to fulfill a PCCP for a SaMD project to accelerate product release cycles

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