Project management development of a class IIb/ III product
Detailed description
THE COMPANY
Berlin Heart GmbH – an internationally active medical technology company in the field of mechanical cardiac support.
THE TASK
For a central development project of an extracorporeal cardiac support system (class IIb/ III) with planned worldwide approval (CE & FDA) a new project management was sought.
OUR SOLUTION
3R LifeScience took over the project management and reorganised the project. This included selecting new development partners, restructuring the project and going through the development phases again. Technical solutions, intended purpose and approval strategy were scrutinised in detail and in some cases replaced by new approaches.
The project involved several external development partners, around 70 project members and a budget in the 2-digit million euro range.
CLIENT BENEFIT
3R LifeScience managed the project from design input through to verification. Our special position as external project manager and the associated objectivity enabled smooth collaboration between our client and the external development partners, even in conflict situations. Despite the problems that arose, our risk-based planning approach kept the project on budget and on time.
Specifically, this was achieved:
- Successful completion of product development
- Compliance with the development budget
- Manufacturing transfer incl. manufacturing, maintenance and logistics contract
- Life Cycle Management
- Completion of approval documents for CE & FDA
Berlin Heart says thanks
“When words were followed by actions and actions by results, I was more than convinced! Thanks to 3R LifeScience, we were able to successfully complete more than a singular product development and bring a product to market that has a great impact for our patients.
In addition, we were able to do a great deal of groundwork of an organizational nature within the company, from which we will benefit in the long term.”
Sven-René Friedel
General Manager,
Berlin Heart GmbH
Patients say thanks
“We understand that the new medical device regulations affect many organisations and raise many questions.”
Together with one of our experts, you clarify your requirements and questions. If cooperation appears helpful, we will arrange a workshop with you.
If you already have clarity about your project requirements and now need support as soon as possible, do not hesitate to call us.