Medical device program management
NextPhase Medical Devices is committed to providing thorough and comprehensive Program Management Services. Our experienced Project Managers leverage their skills and knowledge to navigate customers' development and manufacturing projects through the rigors of the ISO-13485 and FDA QSR regulatory environment. The most current medical device program management techniques and tools are efficiently implemented.
The Project Manager integrates engineering talent, technology solutions and vended services into our project models ensuring that these resources are efficiently allocated, providing "Concept to Customer" solutions.
Each project is assigned a Project Manager. The Project Manager's responsibilities include scheduling, budgetary reporting, partner management and asset resource allocation.
For Manufacturing services, the Project Manager is supported by an NPD engineer and key manufacturing engineering, Quality, Supply Chain, and production resources.
For Engineering services, the Project Manager is supported by the Engineering Team Leader who is dedicated to one project only and manages the workflow, vendor relations, technology development, task development, and schedule.
The Project Manager and/or Team Leader interacts with the customer daily as needed. He or she will be responsible for weekly scheduled formal project updates for all stakeholders. NextPhase Medical Devices leadership is included in our program management model as they are routinely updated by the Project Managers. Monthly management meetings are scheduled where higher-level scheduling, budgetary and technology issues are discussed.