A tailored course, built for your situation
Mastering ISO 22301 for Tenured Program Managers in MedTech
Turn business continuity expertise into higher-margin engagements and strategic influence across global project portfolios
$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
Tenured Program Manager in regulated MedTech environment with cross-functional delivery experience and growing responsibility for operational resilience and compliance integration
Who this is not for
Entry-level coordinators, project assistants, or practitioners without direct ownership of program continuity or compliance integration decisions
What you walk away with
- Identify and prioritize high-impact continuity initiatives that align with enterprise risk appetite
- Design ISO 22301-compliant frameworks tailored to complex medical device project lifecycles
- Lead cross-functional readiness assessments with confidence and executive clarity
- Leverage continuity documentation as a strategic asset during internal audits and vendor reviews
- Position yourself as the go-to practitioner for high-visibility resilience engagements
The 12 modules (with all 144 chapters)
Module 1. Understanding ISO 22301 in the MedTech Context
Lay the foundation with ISO 22301 principles specifically adapted to medical technology environments. Learn how business continuity intersects with device safety, regulatory reporting, and supply chain resilience. This module reframes compliance as an enabler of reliable delivery and trust.
12 chapters in this module
- What ISO 22301 means for MedTech
- Core clauses and their operational impact
- Mapping to product lifecycle stages
- Regulatory drivers beyond FDA
- Linking continuity to quality objectives
- Differences from ISO 9001 and ISO 13485
- Role of risk management frameworks
- Executive expectations on resilience
- Continuity vs disaster recovery
- Stakeholder communication protocols
- Document control expectations
- Audit readiness fundamentals
Module 2. Business Impact Analysis for Medical Devices
Conduct targeted impact analyses that prioritize critical functions in product development and post-market support. Learn to quantify downtime costs specific to device manufacturing, clinical support, and regulatory submissions using real-world templates.
12 chapters in this module
- Defining maximum tolerable downtime
- Identifying critical systems and data
- Regulatory obligations during outages
- Clinical impact assessment
- Supply chain vulnerability mapping
- Stakeholder interview techniques
- Data collection instruments
- Prioritizing recovery sequences
- Documenting assumptions and constraints
- Aligning with quality event logs
- Reviewing with clinical teams
- Validating with operations
Module 3. Risk Assessment and Treatment Planning
Apply ISO 31000-aligned methods to identify threats to business continuity in MedTech environments. Develop risk treatment plans that integrate with existing quality and compliance workflows.
12 chapters in this module
- Threat identification methods
- Likelihood and impact scoring
- Mapping risks to ISO 22301 clauses
- Integrating with CAPA systems
- Vendor risk considerations
- Cybersecurity overlap
- Facility and logistics risks
- Workforce availability planning
- Risk register construction
- Treatment options matrix
- Ownership assignment
- Tracking effectiveness
Module 4. Continuity Strategy Development
Design recovery strategies that meet MedTech reliability standards. Learn how to evaluate options like alternate sites, data replication, and workforce mobilization with regulatory compliance in mind.
12 chapters in this module
- Evaluating recovery time objectives
- Alternate site requirements
- Data backup and restore validation
- Workforce continuity planning
- Emergency response coordination
- Regulatory reporting during crises
- Medical device recall integration
- Field service continuity
- Post-market surveillance access
- Documentation recovery paths
- Supplier engagement plans
- Testing frequency guidelines
Module 5. Plan Development and Documentation
Build comprehensive continuity plans that meet auditor expectations and support rapid execution. Focus on clarity, accessibility, and integration with existing SOPs.
12 chapters in this module
- Structure of a compliant continuity plan
- Roles and responsibilities matrix
- Crisis communication protocols
- Regulatory notification triggers
- Internal escalation paths
- External stakeholder coordination
- Documentation control
- Version management practices
- Integration with quality manuals
- Change control alignment
- Access and distribution rules
- Review and approval cycles
Module 6. Training and Awareness Programs
Develop training materials that resonate with technical and clinical staff. Ensure continuity knowledge is retained and actionable across diverse teams.
12 chapters in this module
- Audience segmentation
- Learning objectives by role
- Training delivery formats
- Content for engineering teams
- Clinical staff engagement
- Field service training needs
- Regulatory refresher content
- Documentation access training
- Awareness campaign design
- Feedback collection
- Compliance tracking
- Annual refresh planning
Module 7. Testing and Exercise Methodology
Design realistic tests that validate plan effectiveness without disrupting operations. Learn how to document findings and drive improvements.
12 chapters in this module
- Test planning fundamentals
- Types of exercises
- Scheduling around product cycles
- Involving clinical teams
- Regulatory constraints on testing
- Vendor participation
- Documentation requirements
- Performance metrics
- Lessons learned capture
- Follow-up tracking
- Audit evidence collection
- Continuous improvement loop
Module 8. Monitoring and Maintenance
Establish routines to keep plans current and relevant. Learn how to trigger updates based on product changes, new regulations, or organizational shifts.
12 chapters in this module
- Change detection triggers
- Product lifecycle integration
- Regulatory update monitoring
- Organizational change tracking
- Facility and IT changes
- Supply chain updates
- Review frequency standards
- Version control practices
- Stakeholder sign-off process
- Archive and retrieval
- Status reporting
- Compliance verification
Module 9. Incident Response Coordination
Lead effective response during real disruptions. Focus on clear communication, regulatory adherence, and minimizing impact on patient safety.
12 chapters in this module
- Activation criteria
- Initial response protocol
- Crisis team formation
- Regulatory reporting timelines
- Field service mobilization
- Patient support continuity
- Data integrity assurance
- Post-event documentation
- Internal investigation alignment
- Vendor coordination
- Public messaging guidelines
- Lessons learned initiation
Module 10. Auditor and Regulator Readiness
Prepare confidently for audits and inspections. Understand what evidence to maintain and how to present continuity efforts effectively.
12 chapters in this module
- Common audit focus areas
- Evidence retention standards
- Document presentation
- Response preparation
- Mock audit exercises
- Gap identification
- Remediation tracking
- Regulatory inspector expectations
- Cross-functional coordination
- Previous finding review
- Communication protocols
- Follow-up response
Module 11. Integration with Quality Management Systems
Align ISO 22301 with ISO 13485 and internal quality processes. Eliminate silos between compliance programs.
12 chapters in this module
- Overlap with design controls
- CAPA integration
- Nonconformance linkage
- Internal audit coordination
- Management review inclusion
- Document control alignment
- Training synergies
- Risk management integration
- Supplier quality interface
- Post-market feedback
- Corrective action triggers
- Metrics consolidation
Module 12. Strategic Influence and Advancement
Position yourself as a leader in organizational resilience. Learn to advocate for continuity as a value driver, not just a compliance requirement.
12 chapters in this module
- Communicating value to leadership
- Budget justification techniques
- Project selection strategy
- Cross-functional collaboration
- Thought leadership development
- Industry engagement
- Certification strategy
- Benchmarking performance
- Mentorship opportunities
- Career advancement paths
- External speaking
- Publication ideas
How this maps to your situation
- New regulatory pressure requiring formal business continuity planning
- Expansion into new geographies with different resilience expectations
- Recent incident exposing gaps in continuity planning
- Desire to transition from compliance follower to strategic leader
Before vs. after
Before
Reactive to compliance demands, handling continuity as an add-on task
After
Proactively selected for high-impact projects with influence across functions
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: 60-90 minutes per week over 12 weeks to complete all modules and apply templates
If nothing changes
Continuity remains a checklist exercise, limiting visibility and career growth
How this compares to the alternatives
Unlike generic ISO 22301 training, this course is tailored to MedTech program managers and focuses on real-world application, strategic positioning, and financial upside.
Frequently asked
Is this course specific to medical technology environments?
Yes, all examples, templates, and scenarios are based on MedTech compliance and delivery challenges.
How is the course structured?
12 modules, each containing 12 chapters (144 chapters total).
Will I receive certifications upon completion?
No, this is a skills and implementation course. It prepares you to lead ISO 22301 initiatives but does not grant official certification.
$199 one-time. 60-90 minutes per week over 12 weeks to complete all modules and apply templates.
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