Our Project Managers Take you From Scope to Product Launch
From idea, concept and technology development to product development and ramp up. Ending up with a final MDR/FDA approval. You get solid plans and projects driven with continuously focus on mitigating project risks. We will efficiently help you through the whole development process towards a finished, user-friendly and MDR/FDA certified medical device.
Our Capabilities
We offer following services in the area of project management with an R&D method/tool box:
VAVE
QCD
Design Review – DFM & DFA
Project Risk
Governance
Portfolio & Resource Management
Stakeholder Management
Extensive Experience in Managing Projects
Our project managers have extensive experience in managing R&D projects or related projects for RA or QA. Combining with our specialized expertise, like User Experience, Simulation and Modeling and Usability Engineering, we aim for high innovation and robust design to support market success and reduce cost in production – ensuring we are in compliance during the whole project lifetime.
When executing projects for you as a client, we often find new and unidentified areas to be optimized, which can eventually influence the progress of the current project – and sometimes even the entire project portfolio. This can have an impact on your business performance, in both the short and long run.
Our senior project managers can help you regain control with your project portfolio by helping with implementing a resource management process for all programs and projects. We support program and project managers in building comprehensive plans, including resource needs, ensuring core milestones are met and launches happen on time.
Efficient Project Risk Management and Milestone/Detail Planning
Project managers often need leadership support and clearer guidance on executive effective risk management to enable efficient mielstone and detailed project planning. They often face difficulties in the dialogues with steering groups due to unclear roles and responsibilities, and a lack of support to the project, which often leads to significant and costly delays.
With this approach, the ground rule “a deal is a deal” will dominate the mindset and behavior among project members and the project manager, securing agreed targets and alignment with the steering group’s goals for each project.
WANT TO KNOW MORE?
Get in Touch
Do you want to know more or didn’t you find what you were looking for? Our Project Managers look forward to hearing from you.
We Have the Expertise to Take You From A to Z
Whether you need a single competency or a combination of skills, our experts in Design & Development are ready to assist you through the entire process. Based on the specific needs of the project, we assemble the ideal team of specialists.
We are able to integrate advanced manufacturing knowledge into the earliest design phase and minimize the number of iterations. Our complete offering takes your project seamlessly through the entire value chain – From Imagination to Realization.
Check out all our areas of early-stage design expertise.
Related Cases
An Anesthesia Workstation
A full Risk Management process was developed for a new anesthesia workstation. We facilitated the development of documents and procedures to speed up the CE marking for the current device as well as future development projects.
Meeting the Requirements of IEC 62366
We assisted with planning and documenting the usability engineering process according to IEC 62366 while at the same time laying out procedures and documentation for future products approvals.
A New Platform Solution for Regulating Ventilation
A complex product redesign for efficient assembly and customization, which reduced production times by more than 25%.
