Ensuring quality: a major challenge in digital health
In an industry where safety, reliability, and compliance are essential, quality is not just a regulatory requirement: it is a prerequisite for ensuring safe and effective solutions.
At Evolucare, our quality department plays a central role in the continuous improvement of our software and services.
How does this department work? What certifications guarantee the compliance of our products? And how do we anticipate regulatory changes related to AI? Take a look at the heart of a key department in our commitment.
Quality assurance: a cross-functional and strategic role
Much more than just process control, the quality department acts as a conductor to ensure the excellence of our software solutions.
Its main tasks:
✅ Ensure compliance with applicable standards and regulations
✅ Support teams in optimizing quality processes
✅ Provide training and raise awareness among employees regarding QMS requirements
✅ Oversee certification and compliance initiatives
Our certifications, a guarantee of trust
To guarantee the quality of our products and strengthen our customers’ trust, we are committed to several certification processes:
🔹 ISO 9001 – Quality Management System (QMS) obtained in 2014
🔹 ISO 13485 – Specific to medical devices, obtained for the first time in 2014
🔹 MDR Certification – Compliance with European medical device regulations obtained in 2024
🔹 ISO 27001 & HDS – Health data security obtained in 2023, supported by another service.
🔹 Qualiopi – Quality of training provided obtained in 2022, managed by another service.
Planning responsibly: new AI and cybersecurity requirements
Our quality approach does not stop at the present: it is part of a strategy to anticipate new European requirements.
We are already preparing to integrate future standards such as:
🔸 ISO/IEC 42001 – First standard dedicated to artificial intelligence, for responsible, ethical, and transparent use
🔸 AI Act – European regulation imposing a strict framework for the use of high-risk AI in DM software solutions
🔸 Cyber Resilience Act (CRA) – Future European regulation on cybersecurity, imposing enhanced requirements throughout the software lifecycle
The continuous improvement process at Evolucare