Agile and Compliance in Medical Devices
(CT-IS103)
Agile and Compliance in Medical Devices
(CT-IS103)

This training is designed for medical device product development teams working under strict regulatory frameworks. Participants will learn how to align Agile practices with ISO 13485, ISO 14971, and FDA 21 CFR Part 820 compliance requirements. The course focuses on embedding traceability, validation, and documentation into Agile workflows without sacrificing speed or collaboration.

🎯 Learning Objective

By the end of this training, participants will be able to:

  • Map Agile artifacts (stories, backlogs, increments) to regulatory structures like DHF
  • Ensure traceability across requirements, design, and verification
  • Integrate design reviews and documentation checkpoints in Agile cadences
  • Understand the compliance roles of Scrum Master, QA, and engineering leads
  • Prepare for audits and regulatory submissions with Agile evidence
  • Align sprint cycles with validation and release readiness criteria

📌 Who Should Attend

Regulatory affairs and quality assurance professionals
R&D leads in medical devices (hardware, firmware, software)
Product Owners, Scrum Masters, and technical leaders
Validation and verification engineers

Level: Advanced

Team Format: Cross-functional teams preferred

🛠️ Format & Duration

Format: In-person / Virtual
Duration: 2 Days
Delivery Style: Domain examples, compliance walkthroughs, Agile simulations

🧭 Customization Options

Optional modules for IEC 62304 (software), MDR (EU), or local regulatory pathways.

🧩 Key Topics

  • Introduction to ISO 13485, ISO 14971, and FDA 21 CFR Part 820
  • Mapping Agile artifacts to regulatory documentation
  • Design History File (DHF) and traceability matrix
  • Design inputs, outputs, and risk management in an Agile flow
  • Sprint-based validation and verification planning
  • Agile roles in compliance: QA, Scrum Master, Tech Lead
  • Release readiness reviews and audit simulation
  • Documentation automation and digital traceability tools

🔗 Related Trainings

  • CT-F105: Agile for Hardware and Systems Engineering
  • CT-F109: Agile in Regulated Environments
  • CT-M104: Agile Metrics and Reporting Essentials