Certified Medical Software Engineer (CMSE) Certification Program by Tonex
This program equips professionals to design, build, and maintain high-reliability medical software across the full lifecycle, from requirements through post-market surveillance. Participants learn regulatory expectations (IEC 62304, ISO 14971, FDA 21 CFR 820), risk management, usability engineering, and evidence-driven verification and validation aligned with Agile and DevOps.
Emphasis is placed on safety classification, hazard controls, traceability, and clinical context to ensure performant, resilient systems that meet quality and compliance needs. The curriculum addresses secure design patterns and secure deployment practices in connected and cloud-enabled medical ecosystems. The cybersecurity impact is substantial as participants learn to reduce attack surface, protect PHI, and sustain safety under adverse conditions. Graduates can embed cybersecurity thinking into requirements, architecture, testing, release, and operations without slowing delivery.
Learning Objectives
- Apply lifecycle processes aligned with IEC 62304 and FDA guidance
- Translate clinical risks into software safety requirements
- Build traceability from requirements to tests and evidence
- Implement V&V strategies that fit Agile and CI/CD pipelines
- Integrate usability, risk, and reliability into acceptance criteria
- Operationalize post-market monitoring and change control
- Strengthen cybersecurity posture across design, test, and operations with measurable controls
Audience
- Software Engineers and Architects
- Quality and Regulatory Engineers
- Product Managers and Clinical Engineers
- Test/Validation Engineers
- DevOps and Site Reliability Engineers
- Cybersecurity Professionals
- Compliance and Risk Managers
Program Modules
Module 1: Lifecycle Foundations and Standards
- IEC 62304 scope
- Class A/B/C mapping
- Risk-driven planning
- Quality system links
- Traceability strategy
- Agile compliance fit
Module 2: Requirements, Risks, and Architecture
- User and system needs
- Hazard analysis flow
- Security requirements
- Safety mechanisms
- Architecture patterns
- Interface contracts
Module 3: Agile Development and DevOps for MedTech
- Definition of Done
- CI/CD with gates
- Code quality rules
- Secure coding guards
- SBOM generation
- Change control
Module 4: Verification and Validation Excellence
- Test design methods
- Requirements coverage
- Automation strategy
- Non-functional tests
- Evidence packaging
- Anomaly handling
Module 5: Cybersecurity and Privacy Engineering
- Threat modeling basics
- Secure configuration
- Data protection/PHI
- Vulnerability handling
- Incident readiness
- Patch and updates
Module 6: Release, Post-Market, and Compliance
- Release readiness
- Real-world evidence
- Complaint trending
- CAPA integration
- Field updates plan
- Audit preparation
Exam Domains
- Regulatory and Quality Systems
- Requirements, Risk, and Safety Engineering
- Secure Architecture and Design Controls
- Verification, Validation, and Evidence Management
- DevOps, Release, and Post-Market Practices
- Data Protection, Privacy, and Compliance Operations
Course Delivery
The course is delivered through a combination of lectures, interactive discussions, case-based walkthroughs, and project-based learning, facilitated by experts in the field of Certified Medical Software Engineer (CMSE). Participants will have access to online resources, including readings, standards mappings, templates, and tools for practical exercises.
Assessment and Certification
Participants will be assessed through quizzes, assignments, and a capstone project. Upon successful completion of the course, participants will receive a certificate in Certified Medical Software Engineer (CMSE).
Question Types
- Multiple Choice Questions (MCQs)
- Scenario-based Questions
Passing Criteria
To pass the Certified Medical Software Engineer (CMSE) Certification Training exam, candidates must achieve a score of 70% or higher.
Ready to elevate medical software safety, compliance, and cybersecurity without slowing delivery? Enroll in the CMSE program by Tonex to build evidence-ready, secure, and reliable solutions for clinical impact.