Software security is not a constraint, it is a collective strength that promotes trustworthy digital health.
In the digital health sector, the security of software solutions is essential. At Evolucare, this requirement is integrated from the earliest stages of design thanks to a structured risk management approach, governed by the ISO 14971 standard.
This approach makes it possible to anticipate dangerous situations and apply corrective and preventive measures to ensure the safety of both professionals and patients.
A recognised method for safe products
ISO 14971 is the international benchmark standard for managing risks associated with medical devices. It defines a rigorous analysis method:
- hazard identification,
- risk estimation and evaluation,
- implementation of control measures,
- monitoring of their effectiveness through time.
This rigorous methodology makes it possible to address very real risks, particularly those that could affect patient safety in the event of configuration errors, misuse, or software failure.
An agile and collective process!
Risk management is not just a quality issue: it is a shared dynamic. It involves R&D teams, business experts, product managers and quality representatives at every stage of development.
This collaborative and agile approach makes it possible to reconcile innovation, performance and safety, while complying with European regulatory requirements.
An agile process is needed to address security throughout the development process. The idea is to identify risks as early as possible to avoid stifling innovation later on.
Concrete examples in the field
Software security relies on rigorous risk analysis right from the design phase. Take the example of prescribing medication: one of the risks identified is errors related to a patient’s known allergies. To avoid significant risk to the patient, our software incorporates reference drug databases that automatically check prescriptions. This mechanism prevents and alerts the prescriber to the dispensing of inappropriate treatments in the event of incompatibility. Ultimately, it reduces the risk of inappropriate drug prescriptions.
An approach that builds trust
At Evolucare, product safety is a cornerstone of our commitment to quality. It is based on a proven method, rigorous management and close cooperation between teams. This approach guarantees reliable, secure software that complies with industry requirements, but above all, it boosts the confidence of healthcare professionals and patients who use them every day.