Design Verification & Validation for Regulated Markets Training by Tonex
This course provides a comprehensive understanding of design verification and validation (V&V) processes in regulated industries. It explores key standards, documentation, and compliance frameworks required for product approval. Emphasis is placed on regulatory environments such as FDA, ISO, and IEC. The course highlights how rigorous V&V enhances product safety and reliability. Impact on cybersecurity is addressed through secure-by-design principles and risk mitigation strategies in regulated systems. Participants gain insights into ensuring both compliance and protection against emerging cyber threats in high-assurance environments.
Audience:
- Cybersecurity professionals
- Regulatory compliance officers
- Quality assurance engineers
- Systems engineers
- Product development managers
- Risk management specialists
Learning Objectives:
- Understand design verification and validation in regulated markets
- Learn regulatory frameworks like FDA, ISO, and IEC standards
- Explore documentation and traceability requirements
- Identify how V&V practices support cybersecurity goals
- Apply risk-based approaches to V&V in product development
Course Modules:
Module 1: Introduction to V&V in Regulated Markets
- Definition of verification and validation
- Difference between V&V and testing
- Importance of V&V in regulated environments
- Overview of regulated markets (medical, aerospace, etc.)
- Key regulatory bodies and standards
- Impact of non-compliance
Module 2: Regulatory Standards and Requirements
- FDA 21 CFR Part 820
- ISO 13485 and ISO 9001
- IEC 62304 for software lifecycle
- Risk-based compliance approach
- Validation requirements across industries
- Global regulatory trends
Module 3: V&V Planning and Documentation
- Creating a V&V plan
- Requirements traceability matrix
- Protocols and templates
- Test case design and traceability
- Review and approval workflows
- Documentation best practices
Module 4: Design Controls and Risk Management
- Design input/output control
- Hazard analysis and risk assessment
- Design failure modes and effects analysis (DFMEA)
- Secure design practices
- Cybersecurity threat modeling
- Risk control validation
Module 5: Cybersecurity in Verification & Validation
- Cybersecurity risk in regulated systems
- Secure-by-design V&V strategies
- Validation of cybersecurity requirements
- Threat and vulnerability assessments
- Regulatory focus on digital security
- Integrating cybersecurity into design reviews
Module 6: Best Practices and Industry Case Studies
- Real-world V&V failures and lessons learned
- Successful compliance case studies
- Audit readiness and continuous improvement
- Common V&V challenges and solutions
- Aligning V&V with product lifecycle
- Tips for efficient regulatory submission
Join Tonex’s Design Verification & Validation Training to master regulatory V&V processes and strengthen your products against compliance and cybersecurity risks.