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Quality, Conformity, Scientific and Medical Validation

 

Quality & regulatory compliance

Participating in the digital revolution of medicine is a stimulating challenge that animates us every day.

This transformation is largely based on the harvesting and exploitation of health data.

Recognizing the challenge of this responsibility, we work by taking care to apply best practices to protect this data, its storage and access.

We take a proactive approach to consider the recommendations of the competent health data authorities from the start of our projects.

 

Protection and security of personal data

In accordance with the General Data Protection Regulation (GDPR), all personal data collected by Ad Scientiam are securely processed.

Health data collected as part of our software solutions is stored at an authorized host of health data (HADS). A consent specifying the purpose of the collection, is asked to the user before any processing carried out on his personal data.

 

Design

Our software solution design follows applicable regulatory and normative requirements, such as ISO 14971 for risk management, IEC 62304 for software development, or ISO 62366 for usability.

It relies on the expertise of a multidisciplinary team of computer engineers, ergonomists, Regulatory & Quality Manager, PhD in Signal Processing and Algorithmology, clinicians, PhD specialists in Clinical Research, and our entire ecosystem (Pitié-Salpetriere, other hospitals, learned societies and patient associations.)

 

Scientific and medical validation

Before commercialization, significant resources are invested in R&D in conducting clinical studies to test and validate our products (feasibility studies, proof of concept and validation studies).

Our studies guarantee compliance with international and European regulations by following ICH (International Conference on Harmonization) and GCP (Good Clinical Practices).

They are therefore conducted in accordance with the CNIL reference methodology MR-001 and validated by the ANSM and the ethics committees.

 

CE / 510k Marking

Our Medical Devices are CE marked in accordance with the essential requirements of European Directive 93/42/EEC.

Regarding the US market, our medical devices require the submission of a 510k ("510k clearance") file to the FDA (Food & Drug Administration).

 

Quality Management System

In order to always improve the quality of our products and better control the risks, we initiated an ISO 13485 certification process of our Quality Management System as a manufacturer of Medical Devices.

In addition, our goal is to meet the FDA requirements for "Quality System Regulation" in accordance with 21 CFR part 820.

 

Distribution

All our Medical Devices are declared to ANSM before being made available on the French market.

Finally, the launch of our products outside France are declared to the competent authorities of each country concerned, in accordance with local legislation in force.