Lifecycle of implantable medical devices (prostheses or implants) is complex.
Many laws, regulations and standards regulate their traceability but health scandals still regularly occur.
We are committed to restoring confidence between all stakeholders involved in the lifecycle of implant medical devices, in any field (orthopaedics, traumatology, cardiac surgery, interventional neuroradiology...), both in Europe and USA.
To achieve this aim, we are developping a software ecosystem, compliant with European (MDR 2017/745/UE) and American regulations, and IT interoperability standards to put manufacturers, healthcare institutions and patients closer, into a win-win relationship:
Be compliant with regulations.
Collaborate on a proactive Post Market Surveillance (= PMS).
Make the maintenance of certifications easier.
Improve the design of medical devices.
Evaluate surgical practices.
Accelerate medical research.
Make intra-hospital processes flow better on the entire life cycle of medical devices (pharmacy, operating room, patient records, medical information, finance).
Audit practices and perform continuous improvements in traceability.
Know the features of their medical devices.
Monitor the evolution of their postoperative consequences in order to decrease their recovery period.
Facilitate alerts in case of a material safety problem
We record the Unique Device Identification (UDI) when the implants and prostheses arrive at the healthcare facility. The UDIs and surgical contexts are then identified at the time of surgery, and distributed throughout the healthcare facility's information system to facilitate the continuity of the various processes.
We are looking for different talents:
If your profile matches, do not hesitate to send us your CV and motivation letter.