I-Sep
i-SEP is a French medtech company founded in 2015 in Nantes, specializing in intraoperative autotransfusion and Patient Blood Management. They develop and market innovative, patented blood component separation technology, aiming to improve patient care, simplify physician workflows, and reduce healthcare costs. Their solutions focus on autotransfusion, allowing recovery of both red blood cells and platelets during hemorrhagic surgeries, thus reducing reliance on donor blood and associated risks.
Industries
Nr. of Employees
small (1-50)
Products
Intraoperative autotransfusion system (recovers red blood cells and platelets)
A medical device used during hemorrhagic or high-risk surgery to collect, process and retransfuse a patient’s blood, designed to recover both red blood cells and platelets and to integrate into operating-room workflows.
Intraoperative autotransfusion system (recovers red blood cells and platelets)
A medical device used during hemorrhagic or high-risk surgery to collect, process and retransfuse a patient’s blood, designed to recover both red blood cells and platelets and to integrate into operating-room workflows.
Services
Clinical study support and PMCF/registry services
Design and execution of clinical evaluations, post-market clinical follow-up and registry data collection to monitor safety and performance under MDR.
Device industrialization and consumables manufacturing
Prototype to production workflows including clean-room assembly, validation batches and industrialization of single-use consumables for the autotransfusion system.
Hospital deployment, training and clinical integration
On-site deployment support, user training and workflow integration for operating-room teams to adopt autotransfusion into patient blood management programs.
Regulatory and quality management (internal capability)
Implementation and maintenance of a certified quality management system and support for regulatory submissions, CE marking under MDR and interactions with competent authorities.
Clinical study support and PMCF/registry services
Design and execution of clinical evaluations, post-market clinical follow-up and registry data collection to monitor safety and performance under MDR.
Device industrialization and consumables manufacturing
Prototype to production workflows including clean-room assembly, validation batches and industrialization of single-use consumables for the autotransfusion system.
Hospital deployment, training and clinical integration
On-site deployment support, user training and workflow integration for operating-room teams to adopt autotransfusion into patient blood management programs.
Regulatory and quality management (internal capability)
Implementation and maintenance of a certified quality management system and support for regulatory submissions, CE marking under MDR and interactions with competent authorities.
Expertise Areas
- Intraoperative autotransfusion and cell salvage
- Patient Blood Management (PBM)
- Clinical trial execution and post-market clinical follow-up
- Medical device R&D and prototyping
Key Technologies
- Autotransfusion and intraoperative cell salvage
- Blood component separation and concentration
- Platelet recovery methods
- Filtration cycles aligned with surgical workflow