Certified Health Software Compliance Professional (CHSCP) Certification Program by Tonex
Build expertise in governing the life cycle of standalone health software and digital health apps, from concept through post-market surveillance. This program blends regulatory frameworks, quality systems, clinical safety, usability engineering, and performance verification to align products with global expectations.
You will master documentation, risk management, and validation strategies that withstand rigorous audits and real-world deployment. Cybersecurity is treated as a first-class safety concern, covering threat modeling, secure update mechanisms, and continuous vulnerability management across connected ecosystems. By unifying safety, security, and performance disciplines, CHSCP equips professionals to deliver compliant, resilient, and trustworthy digital health solutions.
Learning Objectives
- Interpret and apply global health software regulations and standards across the product life cycle
- Design and maintain risk-based QMS artifacts that withstand audits and inspections
- Engineer clinical safety, usability, and performance requirements into architecture and workflows
- Validate, verify, and document software to demonstrate intended use and real-world effectiveness
- Integrate cybersecurity controls into safety cases with continuous monitoring and coordinated disclosure
- Coordinate cross-functional compliance programs spanning engineering, clinical, and quality teams
- Prepare actionable compliance roadmaps for new products and post-market changes
Audience
- Product Managers and Owners
- Software and Systems Engineers
- Quality and Regulatory Affairs Professionals
- Clinical Safety and Risk Managers
- Compliance and Audit Leads
- Cybersecurity Professionals
- Health IT Architects and Integrators
Program Modules
Module 1: Regulatory Landscape and Scope
- Jurisdictional mapping and applicability
- Classification and intended use analysis
- Standard selection and tailoring
- Clinical evaluation expectations
- Evidence strategy and gap closure
- Compliance planning and governance
Module 2: Quality Management Foundations
- QMS structure and process ownership
- Design controls and traceability
- Document and record management
- Supplier and SaMD lifecycle controls
- Internal audits and CAPA integration
- Metrics, KPIs, and management review
Module 3: Risk and Safety Engineering
- Hazard identification and taxonomy
- Use-related risk and human factors
- Risk controls and residual evaluation
- Safety cases and assurance arguments
- Verification of risk mitigations
- Post-market signal triage linkage
Module 4: Verification, Validation, Performance
- V&V strategy and acceptance criteria
- Test design and traceable coverage
- Real-world evidence and monitoring
- Model and algorithm performance checks
- Change impact analysis and revalidation
- Release readiness and conformity reports
Module 5: Cybersecurity for Health Software
- Threat modeling and SBOM practices
- Secure development and code integrity
- Identity, auth, and data protection
- Patch, update, and vulnerability handling
- Incident response and coordinated disclosure
- Continuous monitoring and assurance claims
Module 6: Post-Market and Clinical Operations
- Complaint handling and field actions
- PMS plans and vigilance reporting
- Real-time telemetry and analytics
- Configuration and environment control
- Interoperability and ecosystem risks
- Decommissioning and data retention
Exam Domains
- Regulatory Strategy and Classification
- Quality Systems and Design Controls
- Clinical Safety Engineering and Usability
- Verification Validation and Performance Evidence
- Health Software Cybersecurity Management
- Post-Market Surveillance and Vigilance
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 Health Software Compliance Professional. 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 Health Software Compliance Professional.
Question Types
- Multiple Choice Questions (MCQs)
- Scenario-based Questions
Passing Criteria
To pass the Certified Health Software Compliance Professional Certification Training exam, candidates must achieve a score of 70% or higher.
Ready to lead compliant, secure, and high-performing digital health products? Enroll in CHSCP by Tonex today and accelerate your path to trusted healthcare innovation.