Design Controls for Medical Device Development Training by Tonex
Move beyond checklists and build a compliant, resilient design control system that accelerates safe market entry. This course translates 21 CFR 820.30 and ISO 13485 into clear, practical workflows from user needs through verification and validation, design transfer, and post-market feedback.
Medical products now live in a connected ecosystem, so security threats can become safety risks. We address how secure requirements, risk controls, and verification methods reduce attack surfaces across the lifecycle. You will learn how to embed cybersecurity thinking into DHF artifacts, audits, and supplier oversight so safety, effectiveness, and trust are protected end to end.
Learning objectives
- Translate regulatory design control clauses into actionable procedures and templates
- Structure a Design History File that stands up to audits and inspections
- Decompose user needs into testable design inputs and measurable acceptance criteria
- Apply risk management to drive design outputs, verification, and validation planning
- Integrate usability engineering and human factors evidence into design reviews
- Align supplier qualification and change control with device risk profiles
- Embed cybersecurity requirements, threat controls, and verification within the design control system
Audience
- Quality and regulatory affairs professionals
- Product and systems engineers
- Design verification and validation engineers
- Clinical and usability specialists
- Manufacturing and operations leaders
- Cybersecurity Professionals
- Medical device project managers
Course modules
Module 1 – Foundations of Design Controls
- Regulatory intent and scope
- Definitions and core principles
- Lifecycle and phase gates
- DHF, DMR, DHR alignment
- Role clarity and RACI
- Readiness and auditability
Module 2 – From Needs to Inputs
- Voice of customer capture
- Intended use and indications
- Essential performance mapping
- Risk-based design inputs
- Measurable acceptance criteria
- Traceability setup strategy
Module 3 – Design Outputs and Reviews
- Architecture and interface control
- Drawings, specs, and bills
- Software itemization and SBOMs
- Design review planning
- Review evidence and minutes
- Nonconformance capture pathways
Module 4 – Verification and Validation Planning
- Verification strategy and protocols
- Method selection and sampling
- Test automation and tooling governance
- Validation of intended use
- Summative usability alignment
- Protocol deviations and closures
Module 5 – Risk Management Integration
- ISO 14971 linkage points
- Hazard analysis techniques
- FMEA for design decisions
- Risk controls and residuals
- Risk-benefit documentation
- Post-market feed-forward
Module 6 – Cybersecurity and Change Control
- Threat modeling in requirements
- Secure architecture patterns
- Software update and patching
- Security verification methods
- Supplier security assurance
- Change impact and revalidation
Ready to operationalize design controls that satisfy regulators and earn user trust Join Tonex to implement a streamlined, audit-ready system that blends safety, effectiveness, and cybersecurity from concept to commercialization.