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Development Project Management
Planning, scheduling, coordination and execution support from early development through verification, validation and launch readiness.
Medical Device Product Development
Project management that keeps medical device development moving.
Cintegra Technology provides experienced project management and product development support for medical device companies, bringing engineering depth across electronics, software and electromechanical systems to complex development programs.
Focused on the work between the disciplines.
Medical device development requires engineering, quality, regulatory, clinical, manufacturing and business teams to move together. Cintegra helps establish the structure and follow-through needed to keep those efforts aligned.
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Cross-Functional Coordination
Bring engineering, quality, regulatory and other stakeholders together around clear decisions, actions, dependencies and priorities.
03
Requirements & Risk Management
Support requirements, design decisions, risk management and technical documentation so important issues are identified and addressed early.
04
Development Planning
Build practical development plans, work breakdowns, milestones and resource expectations that teams can actually use.
05
Verification & Validation Support
Coordinate test planning and execution activities, resolve cross-functional issues and maintain visibility to completion criteria.
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Program Recovery
Help teams regain control when schedules, decisions, responsibilities or technical issues are creating delays or uncertainty.
Engineering depth with a project management focus.
Experience spans medical device product development, technical project management and regulatory compliance, with work ranging from system development and manufacturing test fixtures to 60601 compliance and usability planning. The emphasis is on practical execution, not process for its own sake.
- Medical device product development from concept through design transfer and production
- Electronics, software and electromechanical system development
- 60601, 62304, 14971 and related medical device compliance activities
- Verification, validation and manufacturing test development
- Technical project leadership, requirements and cross-functional issue management
Have a medical device project that needs experienced project leadership?
Let's discuss the development challenge, where the project stands today, and where additional project management support could make a difference.
Cintegra Technology, Inc.
Medical device product development project management