A tailored course, built for your situation
Mastering ISO 22301 for Senior R&D Engineering Leaders
Build unshakeable continuity frameworks that keep critical medical device systems operational through disruption
$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.
Continuity plans that sit in drawers instead of driving decisions
The situation this course is for
Many engineers treat ISO 22301 as a documentation exercise, not a technical leadership lever, leading to reactive fire drills, duplicated testing, and peer teams bypassing process. When incidents hit, unclear ownership delays response and erodes trust.
Who this is for
Senior R&D engineering leaders in regulated medtech environments who own continuity of critical systems but lack structured frameworks to translate technical work into auditable, enterprise-grade resilience
Who this is not for
Entry-level engineers, quality auditors without technical delivery responsibility, or professionals outside regulated product development
What you walk away with
- Own end-to-end business continuity architecture for regulated device systems
- Produce ISO 22301-compliant documentation that passes internal and external audit without rework
- Design and deploy incident response playbooks that are adopted cross-functionally
- Serve as primary escalation point for continuity decisions across peer engineering teams
- Lead regulator-facing reviews with confidence using evidence-based control mappings
The 12 modules (with all 144 chapters)
Module 1. Foundations of ISO 22301 in Medical Device Engineering
Understand how ISO 22301 applies specifically to R&D environments with life-critical systems, including distinctions from general IT continuity.
12 chapters in this module
- Defining business continuity in medtech R&D
- Scope boundaries for device-specific systems
- Regulatory context: FDA, EU MDR, and ISO alignment
- Stakeholder mapping: internal and external expectations
- Roles in continuity: owner vs. contributor
- Lifecycle integration: R&D to post-market
- Risk appetite for device downtime
- Incident severity tiers for medical systems
- Document hierarchy in ISO 22301
- Evidence requirements for audits
- Version control of continuity plans
- Common misconceptions in engineering teams
Module 2. Business Impact Analysis for Device-Critical Functions
Conduct targeted analyses that identify which R&D functions must remain operational during disruption, with medtech-specific recovery objectives.
12 chapters in this module
- Identifying mission-critical subsystems
- Maximum tolerable downtime for device workflows
- Recovery time objectives by function
- Recovery point objectives for data integrity
- Dependency mapping: hardware, software, people
- Third-party service continuity risks
- Clinical trial implications of delays
- Patient safety thresholds
- Cross-functional validation needs
- Documentation standards for BIA
- Approval workflows for BIA results
- Updating BIA after system changes
Module 3. Risk Assessment and Threat Modeling
Apply structured threat modeling to anticipate disruptions specific to medical device R&D environments.
12 chapters in this module
- Threat categories: natural, technical, human
- Likelihood scoring for engineering environments
- Impact scoring for regulatory exposure
- Single points of failure in lab systems
- Cyber-physical system vulnerabilities
- Supply chain continuity risks
- Personnel availability assumptions
- Facility access limitations
- Legacy system dependencies
- Mitigation feasibility assessment
- Risk register structure and ownership
- Reporting high-risk items to leadership
Module 4. Designing Resilient Architectures
Create system designs that ensure continuity without compromising R&D agility or compliance.
12 chapters in this module
- Redundancy strategies for lab environments
- Failover mechanisms for test systems
- Data replication for R&D workflows
- Cloud vs. on-premise resilience
- Hardware sparing models
- Virtualization for continuity
- Remote access capabilities
- Secure collaboration during incidents
- Audit trail preservation
- Validation requirements for backup systems
- Disaster recovery testing frequency
- Documentation of architecture decisions
Module 5. Developing Incident Response Playbooks
Build actionable, role-specific response plans that guide teams during real disruptions.
12 chapters in this module
- Incident classification schema
- Escalation paths for engineering teams
- War room setup and comms protocols
- Device-specific response checklists
- Regulatory reporting triggers
- Internal comms during incident
- External stakeholder notification
- Legal and compliance holds
- Evidence preservation steps
- Post-incident review process
- Playbook testing schedule
- Version control and distribution
Module 6. Continuity Plan Development
Assemble a comprehensive continuity plan that aligns with ISO 22301 and R&D realities.
12 chapters in this module
- Plan structure and governance
- Integration with existing SOPs
- Roles and responsibilities matrix
- Activation criteria for plan
- Resource requirements by scenario
- Facility recovery strategies
- Data restoration procedures
- Vendor coordination protocols
- Regulatory notification steps
- Plan maintenance schedule
- Training requirements for teams
- Approval and sign-off process
Module 7. Training and Awareness Programs
Ensure teams understand and can execute continuity plans through targeted education.
12 chapters in this module
- Training needs assessment
- Audience segmentation by role
- Delivery formats for engineers
- Hands-on simulation design
- Awareness materials for lab staff
- Refresher training frequency
- Knowledge assessment methods
- Role-specific playbook access
- Feedback collection process
- Training recordkeeping
- Leadership engagement tactics
- Measuring training effectiveness
Module 8. Testing and Exercise Planning
Design and lead validation exercises that prove continuity capabilities.
12 chapters in this module
- Test types: table-top, simulation, full-interruption
- Test objectives and success criteria
- Scope definition for R&D systems
- Scheduling around development cycles
- Participant roles and assignments
- Scenario development methods
- Facilitation techniques
- Evidence collection during tests
- Post-test review process
- Finding remediation tracking
- Regulator expectations on testing
- Test report documentation
Module 9. Maintenance and Continuous Improvement
Keep continuity plans relevant through structured review and update processes.
12 chapters in this module
- Change triggers for plan updates
- Integration with change management
- Version control of documents
- Periodic review schedule
- Key performance indicators
- Audit findings follow-up
- Incident learnings incorporation
- Stakeholder feedback loops
- Technology refresh considerations
- Regulatory change monitoring
- Lessons learned database
- Continual improvement process
Module 10. Internal Audit and Compliance Readiness
Prepare for and lead audits with confidence using complete, evidence-based documentation.
12 chapters in this module
- Audit scope definition
- Evidence collection framework
- Control mapping to ISO 22301
- Interview preparation for engineers
- Finding response protocols
- Gap assessment methods
- Remediation tracking
- Audit report review
- Follow-up requirements
- Audit schedule alignment
- Third-party auditor coordination
- Audit communication plan
Module 11. Cross-Functional Collaboration Frameworks
Lead continuity efforts across engineering, quality, and regulatory teams.
12 chapters in this module
- Stakeholder identification
- Governance committee structure
- Decision rights framework
- Escalation procedures
- Conflict resolution methods
- Communication protocols
- Shared documentation platforms
- Joint testing events
- Regulatory submission alignment
- Vendor continuity oversight
- Resource sharing agreements
- Performance metrics alignment
Module 12. Strategic Leadership in Continuity
Position yourself as the organization’s continuity authority through demonstrated expertise.
12 chapters in this module
- Building credibility with leadership
- Communicating value of continuity
- Budget justification techniques
- Resource prioritization
- Industry benchmarking
- Thought leadership opportunities
- Mentoring junior engineers
- External conference engagement
- Regulatory advisory roles
- Crisis leadership presence
- Succession planning
- Legacy of resilience
How this maps to your situation
- New continuity mandate in R&D
- Preparation for regulatory inspection
- Post-incident process overhaul
- Leadership expectation for resilience
Before vs. after
Before
Continuity planning is fragmented, reactive, and owned by multiple parties without clear leadership.
After
You own the framework, lead the playbooks, and are the named escalation point for all continuity decisions.
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 45 minutes per module, designed for integration into active R&D cycles.
If nothing changes
Without a structured approach, continuity remains ad hoc, exposing critical systems to downtime, increasing audit risk, and leaving peer teams without clear direction during incidents.
How this compares to the alternatives
Unlike generic ISO 22301 training, this course is tailored to senior R&D engineering roles in medtech, with device-specific scenarios, regulator-facing outputs, and peer-escalation dynamics.
Frequently asked
Is this course relevant if I don’t work in IT or compliance?
Yes. It’s designed specifically for senior R&D engineering leaders who own continuity of critical systems but operate outside traditional IT or compliance roles.
How is the course structured?
12 modules, each containing 12 chapters (144 chapters total).
Does the course include templates I can use at work?
Yes. Every module includes downloadable, customizable templates and real-world examples applicable to medtech R&D environments.
$199 one-time. Approximately 45 minutes per module, designed for integration into active R&D 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