A tailored course, built for your situation
Mastering ISO 27701 for Senior Systems Engineers in Medical Device Innovation
Build privacy by design into system architectures faster, with complete compliance artefacts from day one
$199 one-time
24-hour access provisioning
30-day money-back guarantee
Hand-built implementation playbook
12 modules. 12 chapters per module. 144 chapters total.
12 modules, each with 12 chapters (144 chapters total), text-based, plus downloadable templates and a hand-built implementation playbook delivered alongside course access.
Spending too long translating privacy requirements into engineering specs?
The situation this course is for
System changes stall when compliance is an afterthought. Privacy controls get bolted on late, creating rework, delays, and misalignment between engineering and GRC teams.
Who this is for
Senior Systems Engineer in regulated medtech environment, accountable for secure, compliant system design and integration
Who this is not for
This is not for junior engineers, auditors, or standalone privacy officers without technical architecture responsibilities.
What you walk away with
- Produce complete ISO 27701-compliant privacy design documentation in under 48 hours
- Reduce review cycles with compliance teams by using pre-validated control mappings
- Integrate privacy requirements into system design specs without slowing sprint velocity
- Leverage reusable templates for PII mapping, consent management, and data flow documentation
- Anticipate auditor questions and embed responses directly into system artefacts
The 12 modules (with all 144 chapters)
Module 1. Privacy Engineering in Medical Systems
Establish the role of systems engineers in modern privacy implementation, with focus on ISO 27701's alignment to design cycles in regulated environments. Define key inputs and outputs.
12 chapters in this module
- Rise of embedded privacy engineering
- ISO 27701 vs HIPAA and GDPR scope overlap
- Privacy-first system design cycle
- Stakeholder expectations in medtech
- Defining 'compliant by architecture'
- Mapping controls to system layers
- Key deliverables for stage-gate reviews
- Integrating with risk management boards
- Documentation standards for audits
- Version control for privacy specs
- Cross-functional handoff points
- Common misinterpretations to avoid
Module 2. Foundations of ISO 27701
Decode ISO 27701 structure with a focus on engineering applicability. Identify which clauses require technical implementation and which are policy-only.
12 chapters in this module
- Overview of ISO 27701 structure
- Personal data vs personal information
- Scope definition for systems
- Annex A control types by function
- Extension of ISO 27001 controls
- Privacy context of data flows
- Controller vs processor boundaries
- Joint controller considerations
- Explicit consent implementation
- Children data handling requirements
- International data transfer rules
- Retention period alignment
Module 3. Embedding Privacy into System Design
Map privacy controls directly to system architecture decisions. Learn how to document design choices that satisfy both engineering and compliance review boards.
12 chapters in this module
- Privacy by design principles
- Data minimisation in specs
- Purpose limitation at schema level
- Storage limitation implementation
- Integrity and confidentiality defaults
- Right to access enablers
- Right to erasure workflows
- Data portability outputs
- Automated decision making flags
- Privacy notice triggers in UI
- System-generated audit logs
- Controller role in access design
Module 4. Data Flow Mapping at Scale
Create system-level data flow diagrams that satisfy both technical teams and auditors. Use repeatable templates to accelerate documentation without oversimplifying.
12 chapters in this module
- Data flow boundaries for systems
- Identifying PII touchpoints
- Third-party data sharing paths
- Encryption in transit and at rest
- Role-based access patterns
- API data exposure points
- Backup and recovery paths
- Vendor data processing flows
- Cross-border data routes
- Anonymisation thresholds
- Pseudonymisation in design
- Data lifecycle documentation
Module 5. PII Inventory Construction
Generate a complete, auditable inventory of personal information across system components, with traceability to ISO 27701 Annex A controls.
12 chapters in this module
- Defining personal information scope
- Categories of personal data
- Sensitivity classification levels
- Storage location mapping
- Processing activity logs
- Consent mechanism types
- Legal basis documentation
- Purpose alignment checks
- Retention schedule integration
- Deletion trigger design
- Audit trail requirements
- Cross-system data lineage
Module 6. Controller and Processor Obligations
Clarify system-level obligations under ISO 27701 for Medtronic as data controller, and how vendor systems uphold processor responsibilities.
12 chapters in this module
- Controller roles in system design
- Processor obligations in architecture
- Contractual clauses to enforce
- Processor audit rights design
- Sub-processing disclosures
- Vendor risk assessment inputs
- Third-party compliance checks
- Obligations in cloud environments
- Shared responsibility matrices
- Right to audit enablers
- Data processing agreements
- Incident escalation design
Module 7. Privacy Impact Assessment Integration
Embed privacy impact assessment (PIA) requirements directly into system design sprints with pre-built assessment templates.
12 chapters in this module
- PIA triggers in system changes
- High-risk processing flags
- DPIA integration with design
- Stakeholder consultation design
- Risk mitigation controls
- Approval workflow design
- Documentation for regulators
- Ongoing monitoring requirements
- Thresholds for re-assessment
- Automated PIA inputs
- Cross-border PIA rules
- Legacy system exceptions
Module 8. Consent and Preference Management
Design system components that capture, store, and act on user consent in alignment with ISO 27701 and HIPAA expectations.
12 chapters in this module
- Consent as a data object
- Granular opt-in design
- Preference storage models
- Withdrawal workflows
- Audit trail for changes
- Consent linkage to data
- Default-off principles
- Parental consent mechanisms
- Consent expiry handling
- Multi-jurisdiction alignment
- Language-specific notices
- Accessibility compliance
Module 9. Data Subject Rights Fulfillment
Engineer system responses to data subject requests with minimal rework. Ensure right to access, erasure, and portability are built-in.
12 chapters in this module
- Access request ingestion
- Data bundling outputs
- Identity verification design
- Erasure scope definition
- Irreversible deletion patterns
- Portability format standards
- Response time compliance
- Logging fulfillment actions
- Third-party coordination
- Exemptions handling
- Automated workflows
- Audit readiness
Module 10. Secure Development Lifecycle
Integrate ISO 27701 requirements into CI/CD pipelines and system testing phases with zero slowdown.
12 chapters in this module
- Privacy gates in SDLC
- Automated control checks
- Static analysis for PII
- Dynamic testing for leaks
- Code review standards
- Pipeline integration points
- Environment segregation
- Test data anonymisation
- Penetration testing scope
- Vulnerability response design
- Patch deployment triggers
- Incident simulation
Module 11. Audit-Ready Artefact Generation
Produce documentation packages that pass internal and external audits on first submission, using system-native evidence.
12 chapters in this module
- Evidence collection framework
- Control mapping templates
- Narrative writing for auditors
- System-generated reports
- Version-controlled artefacts
- Gap analysis integration
- Remediation tracking
- Management signoff design
- Review cycle reduction
- Cross-team alignment
- External auditor readiness
- Report formatting standards
Module 12. Sustaining Compliance at Velocity
Maintain ISO 27701 alignment across iterative system changes without creating compliance debt.
12 chapters in this module
- Change management integration
- Automated control validation
- Version diff analysis
- Compliance debt tracking
- Rollback impact on privacy
- Patch validation requirements
- Vendor update monitoring
- Architecture review integration
- Training for new hires
- Metrics for compliance health
- Quarterly self-audit design
- Future-proofing for updates
How this maps to your situation
- New system design requiring privacy compliance
- Vendor integration involving personal data
- Internal audit preparation
- Regulatory inspection response
Before vs. after
Before
Spending days translating privacy requirements into engineering specs, only to face rework during compliance review.
After
Generating compliant system designs in hours, with artefacts that pass review the first time.
What's included with your purchase
- 12 modules with 12 chapters each (144 chapters)
- Downloadable templates and worked examples for every module
- Hand-built implementation playbook delivered alongside course access
- 30-day money-back guarantee
Delivery and format
- Course and learning environment access provisioned within 24 hours of purchase
- Hand-built implementation playbook delivered alongside course access
Format: Text-based modules and chapters in the Art of Service learning environment, plus downloadable templates and worked examples for every chapter, plus the hand-built implementation playbook delivered alongside course access.
Time investment: Approximately 12 hours total, designed to be completed in short sessions between project milestones.
If nothing changes
Continuing to treat compliance as a downstream gate risks slowing innovation cycles, increasing rework, and positioning engineering as the bottleneck in time-sensitive medtech deployments.
How this compares to the alternatives
Unlike generic privacy courses, this is tailored to systems engineers in regulated medical environments, focusing on actionable design decisions, not theory. Compared to consulting, it delivers repeatable internal capability at 1% of the cost.
Frequently asked
Is this course relevant if we’re already ISO 27001 compliant?
Yes. ISO 27701 extends ISO 27001 with specific privacy controls. This course shows how to bridge the two in system design, avoiding duplicate work.
How is the course structured?
12 modules, each containing 12 chapters (144 chapters total).
Will this work for cloud-based medical systems?
Yes. The course includes specific patterns for SaaS, hybrid, and cloud-native architectures used in medtech.
$199 one-time. Approximately 12 hours total, designed to be completed in short sessions between project milestones..
Within 24 hours your account in the learning environment is provisioned and the tailored implementation playbook is delivered alongside it.
30-day money-back guarantee·
144 chapters·
Hand-built playbook included·
Account access within 24 hours