Certified Agile Medical Software Developer (CAMSD) Certification Program by Tonex
CAMSD equips medical software teams to blend IEC 62304 with Agile, DevOps, and CI CD to deliver compliant, auditable, and rapidly iterated products for clinical environments. Participants learn safety case thinking, risk driven backlogs, verification strategies tied to user needs, and automated traceability from requirements to release. The program emphasizes secure by design engineering so quality and safety are reinforced by modern delivery practices. Cybersecurity is addressed as a core quality attribute with threat modeling, secure coding, and continuous security testing to protect patient data and clinical workflows. Graduates can align development speed with regulatory expectations while maintaining clinical safety and resilient operations.
Learning Objectives
- Apply IEC 62304 processes within Agile sprints
- Build and maintain a defensible software safety case
- Implement CI CD pipelines with automated validation and traceability
- Integrate ISO 14971 risk controls into user stories and tests
- Orchestrate DevOps workflows for regulated releases
- Strengthen cybersecurity through threat modeling and continuous security testing
- Communicate compliance evidence effectively to auditors and stakeholders
Audience
- Medical software engineers and architects
- Quality assurance and regulatory affairs specialists
- Product owners and Scrum Masters
- DevOps and platform engineers
- Clinical informatics and validation leads
- Cybersecurity Professionals
- Healthcare technology project managers
Program Modules
Module 1: IEC 62304 In Agile Delivery
- Safety class determination workflow
- Lifecycle activities mapped to sprints
- Design control in backlog items
- Risk control linkage to tests
- Verification and validation planning
- Evidence generation per increment
Module 2: Safety Case and Assurance Evidence
- Safety goals and claims structure
- Argument patterns and GSN basics
- Evidence types and quality gates
- Hazard analysis to acceptance criteria
- Nonclinical validation strategy
- Maintaining assurance continuity
Module 3: DevOps and Regulated CI CD
- Pipeline stages for compliance
- Signed builds and provenance
- Policy as code and approvals
- Automated traceability matrices
- Environment segregation strategy
- Release packaging and SBOMs
Module 4: Risk Management With ISO 14971
- Hazard identification techniques
- Risk estimation and evaluation
- Control selection and verification
- Residual risk benefit analysis
- Post market surveillance linkage
- Risk review cadence in sprints
Module 5: Secure Engineering and Cybersecurity
- Threat modeling for clinical use
- Secure coding guardrails and SAST
- Dependency hygiene and SCA gates
- DAST and API security checks
- Secrets management and key rotation
- Incident response hooks in pipelines
Module 6: Verification Validation and Traceability
- Requirements to test coverage rules
- Automated test strategies by class
- Test data management and ethics
- Performance and reliability checks
- Usability engineering integration
- Audit ready reporting and dashboards
Exam Domains
- Agile Compliance Integration Fundamentals
- Safety Case Development and Assurance
- Regulated DevOps and CI CD Controls
- Medical Software Risk and Quality Management
- Secure Design and Clinical Cyber Defense
- Verification Validation and Traceability Engineering
Course Delivery
The course is delivered through a combination of lectures, interactive discussions, hands-on workshops, and project-based learning, facilitated by experts in the field of Certified Agile Medical Software Developer CAMSD. Participants will have access to online resources, including readings, case studies, 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 Agile Medical Software Developer CAMSD.
Question Types
- Multiple Choice Questions (MCQs)
- Scenario-based Questions
Passing Criteria
To pass the Certified Agile Medical Software Developer CAMSD Certification Training exam, candidates must achieve a score of 70% or higher.
Ready to align speed, safety, and compliance in your medical software programs? Enroll in CAMSD by Tonex today and accelerate delivery with confidence.