Secure-by-Design Medical Device Architect Certification Training by Tonex
Modern connected care depends on devices that are safe, resilient, and trustworthy from the first design decision to the last field update. This program equips architects and technical leaders to align secure-by-design practices with FDA and EU MDR expectations while accelerating compliant product delivery. You will translate SPDF, secure SDLC, and system security engineering into actionable architecture patterns for cloud, mobile, BLE, and IoT ecosystems. Strong emphasis is placed on defensible cryptography choices, robust boot and update chains, and supply-chain assurance. The cybersecurity impact is immediate through reduced attack surface, faster vulnerability response, and traceable risk mitigation. Patient safety improves as cybersecurity and safety cases converge.
Learning Objectives
- Apply secure-by-design principles across device, edge, and cloud
- Map FDA and MDR expectations to SPDF and secure SDLC workflows
- Architect resilient BLE and IoT connectivity with least privilege
- Design cryptography, key lifecycle, and HSM-backed secrets at scale
- Demonstrate measurable cybersecurity risk reduction that supports safety claims
Audience
- Medical device architects
- Systems engineers
- Firmware and hardware engineers
- Product and compliance managers
- Quality and regulatory professionals
- Cybersecurity Professionals
Course Modules
Module 1 – Secure Architecture Foundations
- Threat modeling for safety
- Safety and cybersecurity co-engineering
- Security requirements derivation
- Secure partitioning strategies
- Trust boundaries and assets
- Architecture risk metrics
Module 2 – Cloud and IoT Connectivity
- Zero trust for devices
- API and gateway hardening
- MQTT and CoAP security
- Device identity at scale
- Secure telemetry pipelines
- Edge update orchestration
Module 3 – BLE and Mobile Integrations
- BLE pairing modes
- GATT service hardening
- Mobile app trust anchors
- Session management patterns
- Proximity and replay defenses
- PHI privacy safeguards
Module 4 – Hardware and Firmware Security
- Root of trust options
- Secure element selection
- Memory and debug lockdown
- Secure coding for RTOS
- SBOM and component hygiene
- Fault and tamper resistance
Module 5 – Secure Boot and Update
- Chain-of-trust design
- Signed image validation
- Anti-rollback enforcement
- Recovery and safe state
- Secure OTA pipelines
- Update audit evidence
Module 6 – Cryptography and SSE
- Algorithm and mode selection
- Key generation and storage
- Entropy and TRNG checks
- Data at rest protection
- Data in transit controls
- Security case and assurance
Advance your role as the security backbone of connected care. Enroll now to master secure-by-design architecture practices that satisfy regulators, protect patients, and accelerate compliant innovation with Tonex.