A tailored course, built for your situation
Mastering ISO 22301 for Regional Strategy Leads in Medical Technology
Build unshakable rationale for continuity decisions across EMEA markets
$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.
Who this is for
Senior product and strategy leads in regulated medical technology roles with accountability for cross-market rollout and compliance coherence
Who this is not for
Individuals seeking introductory training on ISO standards or general risk awareness programs
What you walk away with
- Articulate the rationale behind each ISO 22301 control using verifiable sources and real-world implementations
- Map continuity requirements directly to EMEA product governance timelines and regional audit expectations
- Produce documented decision trails that survive leadership changes and inspector follow-ups
- Respond confidently to peer challenges with specific examples from equivalent medtech deployments
- Deliver implementation playbooks that align with both corporate resilience policy and local regulatory nuance
The 12 modules (with all 144 chapters)
Module 1. Foundations of ISO 22301 in Regulated Medical Sectors
Understand how ISO 22301 applies uniquely to medical imaging and radiology product lines under EU oversight. Covers scope boundaries, exclusions, and integration with legacy systems.
12 chapters in this module
- Purpose of business continuity in healthcare tech
- Key clauses in ISO 22301 applicable to EMEA rollout
- Differences from ISO 27001 and ISO 13485
- Jurisdictional triggers for activation
- Risk appetite alignment with product safety
- Regulatory touchpoints under MDR and NIS2
- Integration with existing QMS frameworks
- Stakeholder mapping for BC planning
- Defining criticality of radiology workflows
- Setting recovery time objectives
- Documenting assumptions for audit review
- Common misconceptions in medtech
Module 2. Establishing Context and Scope Boundaries
Define organizational context with precision, ensuring compliance without overreach. Learn to justify inclusions and exclusions using precedent.
12 chapters in this module
- Identifying core delivery chains
- Mapping external dependencies
- Classifying data sensitivity levels
- Setting geographic scope limits
- Linking to corporate governance mandates
- Documenting regulatory interface points
- Handling multi-vendor environments
- Defining single points of failure
- Aligning with supply chain obligations
- Setting escalation thresholds
- Version control for scope documents
- Audit readiness checklist
Module 3. Risk Assessment Aligned to Product Lifecycles
Integrate continuity risk evaluation into product development sprints and regional launch calendars.
12 chapters in this module
- Threat modeling for imaging devices
- Failure impact on diagnostic accuracy
- Likelihood ratings based on field data
- Integrating with DHF documentation
- Vendor risk scoring methodology
- Cyber-physical system interdependencies
- Legacy equipment exposure analysis
- Service continuity for cloud platforms
- Data residency and replication risks
- Regulatory reporting implications
- Mitigation hierarchy by cost-benefit
- Documentation for inspector review
Module 4. Business Impact Analysis for Clinical Workflows
Conduct targeted impact assessments focused on extraoral imaging systems and reporting pathways.
12 chapters in this module
- Defining maximum tolerable downtime
- Mapping patient data flow interruptions
- Prioritizing repair over recovery
- Clinical function hierarchy
- Service level agreement alignment
- Financial impact per hour of outage
- Reputation risk quantification
- Legal notice obligations
- Staff safety considerations
- Third-party dependency mapping
- Recovery prioritization matrix
- Validation requirements post-event
Module 5. Continuity Strategy Design for Distributed Teams
Architect resilient response playbooks that account for distributed clinical support and remote diagnostics.
12 chapters in this module
- On-call escalation structures
- Remote access fallback protocols
- Cloud failover configurations
- Backup imaging interpretation pathways
- Vendor emergency support SLAs
- Field service continuity planning
- Secure data transfer alternatives
- Patient notification procedures
- Legal counsel engagement triggers
- Public relations coordination
- Internal communications plan
- Post-event review scheduling
Module 6. Incident Response Planning for Regulated Environments
Develop response protocols that satisfy both technical recovery needs and regulatory disclosure rules.
12 chapters in this module
- Event classification tiers
- Initial containment steps
- Regulatory reporting timelines
- Notifying authorities under MDR
- Documenting decision logs
- Chain of custody for evidence
- Interfacing with cybersecurity teams
- Legal hold procedures
- Media response coordination
- Internal investigation process
- Corrective action tracking
- Audit trail preservation
Module 7. Exercising Continuity Plans in Clinical Settings
Run effective simulations without disrupting patient care or violating compliance boundaries.
12 chapters in this module
- Tabletop exercise design
- Call tree validation
- Simulated escalation to EMEA leads
- Peer review of response quality
- Lessons learned documentation
- Corrective action deadlines
- Test frequency by risk tier
- Third-party participation protocols
- Regulator observation readiness
- Plan update triggers
- Performance metric tracking
- Executive briefing templates
Module 8. Document Control and Audit Preparation
Maintain a living system that passes unannounced audits and inspector follow-ups.
12 chapters in this module
- Version control best practices
- Approval workflows for updates
- Retention requirements
- Document access controls
- Audit trail generation
- Preparing for unannounced review
- Handling document requests
- Cross-referencing ISO clauses
- Evidence collection strategies
- Common non-conformance areas
- Justifying variances
- Corrective action response drafting
Module 9. Management Review and Performance Evaluation
Demonstrate value through measurable outcomes tied to product reliability and market continuity.
12 chapters in this module
- Setting KPIs for resilience
- Reporting to senior leadership
- Budget justification for improvements
- Trend analysis of incidents
- Benchmarking against peers
- Improvement initiative prioritization
- Resource allocation decisions
- Training effectiveness review
- Vendor performance summaries
- Stakeholder feedback integration
- External audit findings review
- Strategic objective alignment
Module 10. Continuous Improvement in High-Stakes Environments
Drive iterative upgrades without introducing instability into critical systems.
12 chapters in this module
- Root cause analysis methods
- CAPA integration
- Change control alignment
- Lessons learned tracking
- Feedback loops from field teams
- Post-mortem facilitation
- Improvement backlog prioritization
- Risk-based change approval
- Validation requirements for updates
- Documentation versioning
- Regulatory impact assessment
- Rollout sequencing by region
Module 11. Integration with Other Management Systems
Coordinate ISO 22301 with ISO 13485, ISO 27001, and internal quality frameworks.
12 chapters in this module
- Common clause alignment
- Shared documentation areas
- Unified audit schedules
- Cross-functional ownership
- Resource optimization strategies
- Policy harmonization techniques
- Glossary standardization
- Training consolidation
- KPI aggregation
- Incident reporting integration
- Corrective action unification
- Executive reporting consolidation
Module 12. Sustaining Organizational Resilience Across Leadership Cycles
Ensure knowledge survives personnel changes and continues to inform product decisions.
12 chapters in this module
- Succession planning for roles
- Knowledge transfer protocols
- Documented rationale archiving
- New leader onboarding
- Policy continuity across reorgs
- Principles over personalities
- Reference-grade decision trails
- Version history preservation
- Stakeholder mapping updates
- External partnership continuity
- Lessons learned repository
- Long-term resilience vision
How this maps to your situation
- Regional strategy development in medical technology
- EMEA-wide rollout of compliance systems
- Cross-functional engagement on resilience planning
- Audit and inspection follow-up scenarios
Before vs. after
Before
Relying on fragmented documentation and ad-hoc justifications when defending continuity decisions.
After
Walking into any discussion with documented sources, precedent examples, and a clear trail of rationale for every ISO 22301 control decision.
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 be completed over 6, 8 weeks with room for integration into ongoing product planning cycles.
How this compares to the alternatives
Unlike generic ISO 22301 training, this course is tailored to medical technology product managers operating across EMEA markets, with direct application to radiology systems and regulatory reporting timelines. It includes implementation-grade templates absent from certification prep courses.
Frequently asked
Is this course aligned with EU MDR and NIS2 requirements?
Yes. The course integrates ISO 22301 with EMEA-specific regulations including MDR and NIS2, with examples from medical imaging deployments.
How is the course structured?
12 modules, each containing 12 chapters (144 chapters total).
Can I apply this to other ISO standards?
The methodology transfers directly to ISO 27001 and ISO 13485, with specific examples provided in later modules.
$199 one-time. Approximately 3 hours per module, designed to be completed over 6, 8 weeks with room for integration into ongoing product planning cycles..
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