SurgiQual Institute is a 10 year old, 20 person company dedicated to medical innovation, with expertise in software development and regulatory affairs.
We have been developing software for the medical field for ten years.
Our achievements (as a subcontractor or a software publisher) meet the many challenges of the medical world, from planning/diagnosis/patient follow-up to image guided surgery.
Our 15 member team masters adequate technologies including programming languages (web, C++/Qt, mobile), 2D/3D imaging and navigation.
SQI track records includes mainly IEC 62304 compliant software but also organizational software (Health Information System for Health) and research oriented projects.
Regarding regulatory affairs, our main activity is to help organization (including research labs) to deliver compliant prototypes for clinical investigations.
We also collaborates with SMEs to help their CE marking objectives.
Our strengths are:
- A six member experienced team in quality and regulatory affairs
- Methodologies certified by LNE-GMED to manage activities of industrialization, manufacturing and finished product control of Medical Devices, performed in subcontracting in the framework of clinical investigations.
We have strong experiences in the management of Medical Devices, Active Implantable Medical Devices and In-Vitro Diagnostic Medical Devices.