Certified Project Manager for Medical Devices (CPMMD) Certification Program by Tonex
This program equips project managers to drive compliant, on time, and cost effective medical device delivery across the full lifecycle. Participants learn to apply PMBOK and ISO 21502 principles to medtech planning, risk, schedule, quality, and stakeholder alignment while coordinating design controls and cross functional teams. Content maps methods to FDA and EU expectations, harmonizing product development with robust governance and measurable outcomes.
Security infused workflows address data integrity, device software updates, and third party dependencies. Cybersecurity considerations are integrated into risk registers, change control, and supplier oversight so teams protect patient safety and business continuity while meeting regulatory expectations. Graduates leave with practical templates, decision frameworks, and communication tools that scale in startups and global enterprises.
Learning Objectives
- Apply PMBOK and ISO 21502 to medtech projects
- Build integrated schedules and regulatory roadmaps
- Structure risk registers and design control evidence
- Optimize resources budgets and vendor performance
- Align stakeholders using clear governance and metrics
- Integrate quality management with verification and validation
- Embed cybersecurity risk treatment in plans and deliverables
Audience
- Project Managers and Program Managers
- Product Managers and Owners
- Quality and Regulatory Affairs Specialists
- R&D and Systems Engineers
- Clinical and Compliance Leads
- Operations and Supply Chain Managers
- Cybersecurity Professionals
Program Modules
Module 1: Tailoring PMBOK to Medical Devices
- Lifecycle mapping
- Phase gate criteria
- Requirements hierarchy
- WBS and deliverables
- Schedule baselining
- Change governance
Module 2: ISO 21502 Governance for Medtech
- Roles and authorities
- Sponsorship model
- Decision registers
- Benefits management
- Assurance activities
- Issue escalation
Module 3: Risk Management and Design Controls
- Hazard analysis
- FMEA and FTA
- Verification strategy
- Validation planning
- Traceability matrix
- Postmarket signals
Module 4: Regulatory Planning and Submissions Roadmaps
- US FDA pathways
- EU MDR mapping
- Technical documentation
- Clinical evidence plans
- Submission timelines
- Inspection readiness
Module 5: Resource Cost and Vendor Management
- Capacity planning
- Skills matrices
- Make or buy
- Supplier qualification
- Contract milestones
- Earned value tracking
Module 6: Quality Metrics and Lifecycle Handover
- KPI dashboards
- Nonconformance trends
- DHF and DMR handoff
- Release readiness
- Service transition
- Continuous improvement
Exam Domains
- Project Governance and Stakeholder Alignment
- Integrated Planning and Scheduling Practices
- Risk and Decision Analytics in Medtech
- Regulatory Evidence and Documentation Management
- Resource Financial and Vendor Control
- Quality Measurement and Lifecycle Readiness
Course Delivery
The course is delivered through a combination of lectures, interactive discussions, hands on workshops, and project based learning, facilitated by experts in the field of Certified Project Manager for Medical Devices. Participants will have access to online resources, including readings, case studies, and tools for practical exercises.
Assessment and Certification
Participants will be assessed through quizzes, assignments, and a capstone project. Upon successful completion of the course, participants will receive a certificate in Certified Project Manager for Medical Devices.
Question Types
- Multiple Choice Questions (MCQs)
- Scenario based Questions
Passing Criteria
To pass the Certified Project Manager for Medical Devices Certification Training exam, candidates must achieve a score of 70% or higher.
Ready to lead compliant and secure medtech projects with confidence Join the CPMMD Certification Program by Tonex and accelerate your path to predictable delivery and regulatory success.