A tailored course, built for your situation
Mastering ISO 22301 for Reliability Engineers in Cardiac Ablation Solutions
Build defensible, high-quality business continuity outcomes that stand up to internal and regulatory scrutiny
$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.
Avoid rework cycles on business continuity submissions that delay sign-off and erode confidence
The situation this course is for
Reliability Engineers invest significant effort in continuity planning, only to face repeated review rounds due to gaps in ISO 22301 alignment. This delays approvals, increases documentation burden, and risks misalignment with quality system expectations.
Who this is for
Mid-career Reliability Engineer in a regulated medical device environment, responsible for system uptime and business continuity planning within a specific therapeutic area
Who this is not for
Directors building enterprise-wide resilience strategy, consultants selling continuity programs, or practitioners outside of medical technology or highly regulated industries
What you walk away with
- Produce ISO 22301-aligned business impact analyses with fewer review cycles
- Apply reliability engineering data directly to continuity scope and recovery objectives
- Document continuity plans that meet both internal quality standards and regulatory expectations
- Reduce rework by aligning reliability testing outcomes with continuity evidence requirements
- Build confidence in review meetings with precise, defensible recovery time objectives
The 12 modules (with all 144 chapters)
Module 1. Understanding ISO 22301 in Medical Device Contexts
Ground the standard in cardiac ablation systems, focusing on patient safety and regulatory alignment. Learn how continuity planning supports device reliability.
12 chapters in this module
- Scope of ISO 22301 in healthcare
- Regulatory drivers in medical devices
- Continuity vs quality systems
- Patient safety implications
- Linking uptime to recovery objectives
- FDA expectations alignment
- EU MDR considerations
- Global supply chain risks
- Legacy systems in scope
- Change control integration
- Audit trail requirements
- Document control mapping
Module 2. Reliability Data for Business Impact Analysis
Turn MTBF, failure mode, and field data into credible inputs for ISO 22301 impact assessments. Strengthen justifications with engineering-grade evidence.
12 chapters in this module
- Using MTBF in RTO setting
- Failure mode severity scoring
- Field data for impact weighting
- Uptime requirements analysis
- Clinical downtime thresholds
- Service level agreement inputs
- Maintenance window alignment
- Spare parts availability
- Single point of failure mapping
- Redundancy validation
- Test records as evidence
- Lifecycle phase considerations
Module 3. Defining Scope with Precision
Narrow the continuity scope to relevant systems in cardiac ablation workflows. Avoid overreach and ensure focus on mission-critical reliability.
12 chapters in this module
- Identifying critical subsystems
- Charting clinical workflows
- Mapping system dependencies
- Excluding non-essential systems
- Vendor-supported systems
- Internal vs hosted services
- Software as a medical device
- Cloud-hosted components
- On-premise infrastructure
- Data backup responsibilities
- Third-party escalation paths
- Support contract alignment
Module 4. Risk Assessment Integration
Link FMEA, FMECA, and reliability risk registers to ISO 22301 risk treatment plans. Show how engineering assessments drive continuity priorities.
12 chapters in this module
- FMEA to risk treatment mapping
- Severity-probability weighting
- Existing controls identification
- Residual risk evaluation
- Risk acceptance documentation
- Escalation thresholds
- Cross-functional review steps
- Mitigation tracking
- Risk register synchronization
- Audit evidence packaging
- Management review inputs
- Continuous improvement loop
Module 5. Recovery Strategy Development
Design recovery approaches grounded in actual system specs and reliability testing. Move beyond templates to engineering-accurate strategies.
12 chapters in this module
- RTO setting from test data
- RPO from data logging frequency
- Failover process validation
- Manual workaround feasibility
- Component-level recovery
- System-level restoration
- Validation requirements
- Parallel run options
- Cutover planning
- Rollback procedures
- Performance benchmarks
- Post-recovery verification
Module 6. Documenting the Business Continuity Plan
Structure plan documents to pass internal review and external audit. Include only what’s defensible and required.
12 chapters in this module
- Policy statement drafting
- Objectives and scope writing
- Roles and responsibilities
- Crisis communication templates
- Technical response playbooks
- Vendor escalation procedures
- Internal coordination steps
- Regulatory reporting triggers
- Plan maintenance schedule
- Training requirements
- Test plan integration
- Version control approach
Module 7. Exercising and Testing Plans
Run tests that generate credible evidence of recovery capability. Align with reliability engineering testing cycles.
12 chapters in this module
- Test frequency planning
- Tabletop exercise design
- Structured walkthroughs
- Technical failover drills
- Partial system tests
- Full interruption simulations
- Test observation roles
- Deficiency logging
- Remediation tracking
- Evidence collection
- Audit-ready reporting
- Lessons learned integration
Module 8. Incident Response Integration
Connect continuity plans to existing incident management workflows. Ensure reliability engineers are in the loop during real disruptions.
12 chapters in this module
- Incident severity levels
- Activation thresholds
- Command chain alignment
- Reliability team roles
- Field alert coordination
- Service disruption comms
- Regulatory notification paths
- Internal escalation steps
- External agency comms
- Legal department alignment
- Public statement prep
- Post-event review
Module 9. Audit Readiness and Evidence Packaging
Package documentation to satisfy ISO 22301 auditors and regulatory reviewers. Focus on clarity, traceability, and defensibility.
12 chapters in this module
- Audit scope preparation
- Evidence checklist creation
- Document version proof
- Testing results compilation
- Management sign-off collection
- Regulatory alignment statements
- Gap justification writing
- Prior audit finding closure
- Cross-reference indexing
- Review meeting prep
- Q&A preparation
- Post-audit follow-up
Module 10. Continuous Improvement from Reliability Data
Use field performance, failure logs, and test outcomes to refine continuity plans. Make updates proactive, not reactive.
12 chapters in this module
- Field failure trend analysis
- Reliability improvement inputs
- Mean time to repair updates
- Failure mode recurrence
- Design change impacts
- Software update risks
- User error patterns
- Environmental factors
- Supply chain changes
- Service model evolution
- Customer feedback review
- Plan update triggers
Module 11. Cross-Functional Alignment
Secure buy-in from quality, regulatory, IT, and operations teams. Frame continuity as shared responsibility.
12 chapters in this module
- Quality team collaboration
- Regulatory affairs alignment
- IT disaster recovery sync
- Operations input gathering
- Clinical specialist roles
- Training coordination
- Change control integration
- Document review process
- Escalation path mapping
- Shared terminology
- Meeting rhythm setup
- Accountability matrix
Module 12. Maintaining Leadership and Oversight
Sustain executive engagement through clear reporting and measurable outcomes. Position continuity as a reliability excellence indicator.
12 chapters in this module
- Executive summary drafting
- KPI selection
- Downtime trend reporting
- Test success metrics
- Risk reduction tracking
- Audit outcome summaries
- Budget justification
- Resource planning
- Leadership review rhythm
- Cross-unit benchmarking
- Lessons sharing
- Program maturity assessment
How this maps to your situation
- When starting ISO 22301 documentation
- During internal audit preparation
- After a regulatory inspection
- When revising business continuity plans
Before vs. after
Before
Spending multiple review cycles refining business continuity documentation, struggling to align engineering facts with compliance expectations
After
Submitting first-time-approved ISO 22301 artefacts grounded in reliability data and defensible rationale
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 3 hours per module, designed to fit around core engineering responsibilities
If nothing changes
Continual rework of continuity documentation, missed deadlines for audit readiness, and weakened credibility when presenting to quality or regulatory reviewers
How this compares to the alternatives
Generic ISO 22301 courses focus on theory or enterprise IT. This course is tailored to medical device reliability engineers who must produce auditable, technically accurate continuity plans in cardiac ablation systems.
Frequently asked
Is this course applicable to medical device regulations?
Yes. It maps ISO 22301 requirements directly to FDA and EU MDR expectations in cardiac ablation systems.
How is the course structured?
12 modules, each containing 12 chapters (144 chapters total).
Can I apply this to ongoing projects?
Yes. Each module includes templates and examples you can adapt to current continuity planning tasks.
$199 one-time. Approximately 3 hours per module, designed to fit around core engineering responsibilities.
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