“Our value comes from understanding both the technical and regulatory landscapes. We can reduce risk early by bringing a more holistic view to planning–something that’s especially crucial for startups and technical teams that may not fully grasp the complete medical device development process.”
–Jim Tiefenthal, Senior Project Manager
CMD MedTech provides comprehensive project management services for medical device development and technical projects. Our team brings extensive experience managing both internal resources and external projects, particularly supporting clients who need additional PM capabilities or technical leadership. As engineers by training who have become project managers, we deliver value-added medical device project management that combines industry expertise with efficient project execution.
Why Choose CMD MedTech for Medical Device Technical Leadership
- Experience managing technical projects across the medical device industry
- Deep understanding of regulatory requirements and their timing
- Ability to scale project management support based on client needs
- Expertise in managing both internal and external resources
- Strong background in systems engineering integrated with project management
- Experience working with established companies and startups
- Understanding of FDA expectations and regulatory requirements
- Ability to reduce development risks through early planning
- Experience managing projects from concept through completion
Pricing for Our Project Management Services
Our medical device development project management services are typically integrated into our broader technical engagements, like medical device engineering. We offer flexible engagement models with both time-and-materials and fixed-price options. Contact us to discuss your project needs and receive a customized proposal.
Project Management Process
Initialization Phase
- Determine project scope and charter
- Define goals and milestones
- Establish baseline requirements
- Identify stakeholders
Planning Phase
- Develop milestone schedules
- Create resource plans
- Establish budgets
- Identify and assess risks
- Plan risk management strategies
Execution and Control Phase
- Implement planned activities
- Monitor progress against milestones
- Manage resources and timeline
- Control project risks
- Maintain stakeholder communication
Closing Phase
- Handle deliverables transfer
- Complete technical documentation
- Conduct internal closeouts
- Transfer project materials to client
Additional Services We Provide
Technical Leadership
Leading development teams through complex medical device projects.
Risk Management
Early identification and management of project risks.
Resource Coordination
Managing internal and external development teams.
Timeline Management
Keeping projects on track while meeting regulatory requirements.
Stakeholder Communication
Regular updates and progress reporting.
Quality System Integration
Ensuring project alignment with quality requirements.
Frequently Asked Questions About Medical Device Project Management
Project management and systems engineering have significant synergy. Our technical background means we bring engineering expertise to project management, often supporting clients through system engineering while helping manage the overall development process.
While we can support projects at any stage, engaging at the beginning allows us to map out everything and streamline the process, helping avoid expensive mistakes and ensuring all necessary considerations are included in planning.
We begin with understanding your users, key performance indicators, target markets, and regulatory plans. For startups, we also need to understand any investment-related milestones that could impact development timing.
Yes, we can scale our involvement for medical device technical leadership according to your needs, from supplementing existing PM capabilities to providing complete project management services.
We help startups understand the complete medical device engineering and development process, including regulatory requirements and documentation needs. We work to manage expectations and create realistic timelines that account for both technical development and regulatory requirements.