Interview with Coraline HALOUANI-PASQUIER
Quality & Regulatory Affairs Manager at Bow Medical
At SantExpo, Bow Medical is announcing a major milestone for its Diane software range: European Class IIb certification. This recognition marks a turning point for the safety and performance of digital medical solutions, particularly in critical care environments.
We spoke with Coraline HALOUANI-PASQUIER, Quality & Regulatory Affairs Manager at Bow Medical, to understand what this certification means for hospitals, clinics and healthcare professionals.
Coraline, can you explain exactly what Class IIb certification involves for Diane?
Coraline HALOUANI-PASQUIER (C.H.P.): Class IIb certification is one of the most demanding levels for medical device software in Europe. It applies to solutions involved in patient care that are likely to have an impact on patient safety. For Diane, this means that every feature and every process has been validated against very strict standards in terms of clinical performance, safety and risk management.
In other words, it provides a high level of assurance regarding the compliance and reliability of the Diane software suite for use in operating theatres and ICUs.
What changes did Bow Medical need to make to obtain this certification?
C.H.P.: Achieving Class IIb is never straightforward. It means strengthening your processes, further structuring traceability, comprehensively documenting every stage of development and testing, and maintaining a high standard of risk management.
Beyond the processes, this certification is above all a collective achievement. It involved many teams across the company, in particular technical management, R&D process management, and all the teams involved in development, quality and operations.
This work required close collaboration, strong commitment and the ability to align very different areas of expertise around a shared goal: ensuring a level of safety and reliability that meets MDR requirements.
We were also supported by external experts, who complemented and challenged our practices, but this success rests first and foremost on the commitment of the Bow Medical teams.
It is this collective investment that now enables us to offer a robust, compliant solution suited to the most demanding environments.
How does this certification affect the experience of users such as anaesthetists and intensivists?
C.H.P.: For healthcare professionals, the main difference is confidence. They know that the data they consult in Diane is reliable, up to date and validated against the strictest European standards.
This translates into faster, safer decision-making, less stress in critical care environments and better coordination across teams. Ultimately, it is the patient who benefits directly from this enhanced safety.
What about hospital decision-makers and IT teams?
C.H.P.: For them, the certification simplifies a great deal. Healthcare facilities do not need to invest time and resources in verifying regulatory compliance: Diane is ready to use and already meets European requirements.
It also makes integration with other hospital systems easier and reduces risk during certification processes.
What are your plans for Diane following this certification?
C.H.P.: We are continuing to invest in innovation and safety. Our goal is to deliver ever more useful features to clinical teams while maintaining the level of safety and performance required by Class IIb. We are also working on analytics modules and clinical decision support tools to help hospitals optimise patient pathways, strengthen risk prevention and improve the overall quality of care.
What would you say to healthcare facilities that are still hesitant about adopting Diane?
C.H.P.: I would tell them that safety and reliability are non-negotiable in environments where people are at the heart of everything we do. With Diane certified Class IIb, they benefit from a robust, compliant and innovative solution that supports teams day to day and delivers tangible improvements in the quality of care.
SantExpo will be the ideal opportunity to see Diane in action and talk to our experts about the benefits of this certification.
To conclude?
C.H.P.: With this Class IIb certification, Bow Medical positions Diane as a benchmark software solution for critical care environments, offering healthcare facilities safety, performance and compliance, while improving clinical practice and patient safety.
The practical benefits of this certification for healthcare facilities
Enhanced patient safety
The information Diane provides to anaesthetists and intensivists is reliable and validated against the strictest European requirements. This significantly reduces the risk of error.
Simplified regulatory compliance
Hospitals and clinics must comply with increasingly complex regulations. Diane provides them with a solution that is already compliant, making audits, certifications and accreditations easier.
Performance in critical care environments
Class IIb certified software must withstand demanding conditions of use and deliver reliable data.
Improved quality of care
By standardising processes and making data more reliable, Diane helps teams optimise their practices and analyse performance for continuous improvement.
