Quality, Conformity, Scientific and Medical Validation
It is a stimulating challenge to participate to the digital transformation of medicine. This transformation relies mainly on the collection of health data. Aware of the challenges created, we are following the best practices to protect these data, their storage and their access. We adopt a proactive approach to take into consideration the recommendations of competent authorities in terms of health data, from the start of our projects.
Our solutions are developed to be flexible and easy to integrate into other systems frequently used. Our team has a strong experience in these questions of interoperability and agile method.
During the entire lifecycle of Ad Scientiam self-assessment solutions, strict procedures are implemented to guarantee the efficiency, the conformity and the quality of each of our software medical devices.
CONCEPTION: Research & Innovation
The conception of our solutions relies on the expertise of a multi-skilled team of clinicians, PhD specialized in clinical research, software engineers...and our entire ecosystem (Pitie-Salepetriere and other hospitals, learned societies and patient associations).
All our process and activities to develop our software medical devices follow Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
From conception to development then user and technical validation tests, our product lifecycle is in line with French and European standards NF EN 62304 (Medical device software - Software life-cycle processes) and NF EN 62366 (Medical devices - Application of usability engineering to medical devices).
VALIDATION by competent authorities
Our solutions follow a rigorous technical and scientific validation process:
Technical validation and CE mark
Our solutions are developed in line with requirements from the ANSM (French Agency for the Safety of Drugs and Health Products). They follow a risk analysis as required by French and European standard NF EN 14971 and are filed for CE mark.
Medical and scientific validation
Before solution commercialization
- Significant R&D resources are invested in clinical studies to test and validate our solutions (feasibility studies, Proof-of-Concept and clinical validation studies before CE mark)
- Our clinical studies follow the ISO standard 14155 "Clinical investigation of medical devices for human subjects", respecting ICH-GCP guidelines
- Our studies are conducted in conformity with reference methodology MR-001 from France CNIL and validated by ANSM and ethics committees.
- We work with key opinion leaders for each studied pathology and build a dedicated scientific committee for each of our solutions.
After solution commercialization:
- We are also conducting clinical studies post-launch, in real-life conditions.
Finally, the launch of our solutions outside of France is supported by the preparation of a submission file for competent authorities of each concerned countries, as requested by national legislation.