Agile Medical Device Software Development Fundamentals Training by Tonex
Modern medical devices demand fast, evidence-driven software delivery without compromising patient safety or compliance. This course shows how to apply Agile methods that satisfy regulators, accelerate iteration, and create verifiable engineering outcomes. You will translate user needs into testable requirements, orchestrate cross-functional collaboration, and maintain audit-ready traceability across the lifecycle.
Strong security practices are embedded throughout sprint planning, CI, and release governance. Expect clear guidance for protecting PHI, clinical data, and intellectual property within Agile pipelines. Robust cybersecurity reduces recall risk, strengthens market trust, and supports resilient postmarket surveillance under real-world threat conditions.
Learning Objectives
- Apply Agile frameworks aligned with ISO 13485 and ISO 14971
- Build end-to-end traceability from user need to verification
- Plan risk-based testing that satisfies regulators and auditors
- Integrate continuous integration with documented evidence
- Design change control that supports rapid iteration
- Strengthen cybersecurity across the lifecycle using secure design, hardening, and validated DevSecOps controls
- Prepare objective evidence packages for submissions and inspections
Audience
- Software Engineers and Tech Leads
- Quality and Regulatory Managers
- Clinical and Systems Engineers
- Product Owners and Scrum Masters
- Validation and Test Professionals
- Compliance and Risk Analysts
- Cybersecurity Professionals
Program Modules
Module 1 – Agile Foundations for Devices
- Agile values and constraints
- Roles and cross-functionality
- Backlogs and user needs
- Definition of Done clarity
- Evidence-ready Agile artifacts
- Sprint reviews with clinicians
Module 2 – Regulatory Pathways and QMS
- ISO 13485 alignment
- IEC 62304 software classes
- 21 CFR 820 expectations
- MDR and IVDR mapping
- Documented change control
- Supplier software oversight
Module 3 – Risk Management and Safety
- ISO 14971 linkage
- Hazard analysis flow
- FMEA and FTA usage
- Risk controls in sprints
- Benefit-risk justification
- Residual risk reporting
Module 4 – Agile Requirements and V&V
- Writing good user stories
- Acceptance criteria patterns
- Requirements decomposition
- Trace matrices automation
- Verification strategy design
- Validation with end users
Module 5 – DevOps Toolchain and Controls
- CI with objective evidence
- Automated unit and static
- Secure coding checklists
- SBOM generation workflow
- Environment configuration baselines
- Release gating policies
Module 6 – Release, Postmarket, Scaling Practices
- Incremental release planning
- UDI and labeling readiness
- Postmarket cybersecurity vigilance
- Complaint and CAPA linkage
- Metrics and leading indicators
- Scaling Agile in regulated firms
Advance device software that is fast, compliant, and secure. Enroll today to master Agile practices tailored for regulated environments and deliver safer, smarter products with confidence.