Project Management for Product Development Essentials Training by Tonex
Momentum in medtech demands disciplined execution that balances speed, safety, and compliance. This course equips product teams with practical, PMBOK and ISO 21502–aligned methods for planning, risk control, and stakeholder governance across the full product life cycle. You will translate strategy into measurable roadmaps, align cross-functional resources, and manage design controls without stalling innovation.
Cybersecurity is treated as a first-order requirement: you’ll integrate secure-by-design thinking into schedules, budgets, and verification plans. Expect guidance on mapping threat surfaces to product risks and tracing mitigations to requirements. Outcomes include predictable timelines, audit-ready artifacts, and resilient delivery across complex medtech portfolios.
Learning Objectives:
- Apply PMBOK and ISO 21502 principles to medtech programs from concept through post-market.
- Build integrated schedules that connect design controls, risk files, testing, and supplier milestones.
- Operationalize risk management with clear owners, thresholds, and decision cadences.
- Translate regulatory pathways (e.g., 510(k), CE) into scope, budget, and resource plans.
- Structure change control, configuration, and traceability to keep design history files audit-ready.
- Embed cybersecurity considerations into plans, risks, and acceptance criteria to meet evolving expectations.
- Communicate progress and issues with concise dashboards and phase-gate readiness criteria.
Audience:
- Product Managers and Program Managers
- R&D and Systems Engineering Leads
- Quality and Regulatory Affairs Professionals
- Manufacturing and Operations Managers
- Clinical and User Research Leads
- Cybersecurity Professionals
- Medtech Founders and Portfolio Leaders
Course Modules:
Module 1 – Foundations and Governance
- PMBOK and ISO 21502 alignment
- Charter, scope, and guardrails
- Stakeholder and RACI modeling
- Phase-gates and decision rights
- Metrics, KPIs, and OKRs
- Communication cadences and reports
Module 2 – Planning and Scheduling
- Work breakdown for medtech
- Critical path and buffers
- Long-lead and supplier integration
- Regulatory timeline mapping
- Cost, contingency, and reserves
- Rolling-wave planning playbook
Module 3 – Risk and Design Controls
- Hazard analysis integration model
- FMEA, ISO 14971 alignment
- Risk registers and thresholds
- Verification and validation linkage
- Traceability from risk to test
- Change control and deviations
Module 4 – Regulatory Strategy Execution
- Pathway selection and evidence
- Design history file essentials
- Clinical and human factors inputs
- Technical file compilation cadence
- Submission readiness checklists
- Post-market surveillance hooks
Module 5 – Resources and Supply Chain
- Capacity and skills planning
- Make-buy and partner models
- Supplier qualification criteria
- Contracts, SLAs, and quality
- Cost tracking and variance
- Ramp-up to transfer plans
Module 6 – Cybersecurity and Resilience
- Secure-by-design requirements
- Threat modeling in backlogs
- SBOM and patching strategies
- Verification and pen-test timing
- Regulatory expectations roadmap
- Incident response and updates
Elevate your medtech execution with a governance model that delivers speed, safety, and compliance—without surprises. Contact Tonex to schedule this course for your team, customize modules to your portfolio, and accelerate confident submissions and market-ready products.