Posos obtains CE class IIb marking providing a complete platform for Medical Software Publishers’ European expansion
Paris, January 9, 2024 - Posos, a medtech company specializing in AI-powered medical prescription assistance, announces that it has obtained CE class IIb marking for its medical devices. This certification, mandatory for any manufacturer wishing to market medical devices in Europe, enables Posos to offer medical software publishers a comprehensive solution to accelerate their European expansion: regulatory compliance, access to a multilingual medical database, state-of-the-art APIs and prescription security widgets. Posos thus offers a unique solution to deploy their solutions not only in France, with the offering being compatible with LAP and Digital Prescription criteria, but also in new European countries, while ensuring quality and safety in drug management for patients.
Summary
A demanding certification serving operational and regulatory excellence
Obtaining CE class IIb marking represents a key milestone for Posos. This certification, one of the most demanding in the European market, validates the robustness of its development processes and the high quality level of Posos' medical devices. It also attests the medtech's ability to meet the strictest standards in terms of performance and safety.
"Obtaining CE class IIb marking is recognition of the performance of our prescription algorithms and of our teams who have built and evolved a software solution meeting the highest standards," emphasizes Rémi Buffet, Head of Quality and Regulatory Affairs at Posos. "Our CE-marked medical devices enable healthcare professionals to be informed about the risks of drug treatments and provide them with associated recommendations to address these risks, thus helping to reduce iatrogenic risks for patients."
An unique solution to accelerate Medical Software Publishers' European expansion
For medical software publishers, having access to Posos's multi-country drug database and CE class IIb-marked algorithms available via APIs or prescription modules represents a real springboard for development in France and across Europe.
This approach significantly reduces the burden, cost, and duration of the certification process and adaptation to local specificities, allowing publishers to focus on their solutions' user experience while ensuring a high level of compliance.
"Until now, publishers who wanted to offer their software in multiple European countries had to develop and maintain a different version of their prescription modules for each market, with significant costs and delays," explains Emmanuel Bilbault, President and co-founder of Posos. "With Posos, they now have a single, compliant, and scalable platform to accelerate their expansion in Europe, benefiting patient safety."
By leveraging Posos's regulatory and and technological expertise, publishers can quickly deploy their solutions in new countries while managing the risks and investments associated with internationalization.
An international ambition serving improved drug management
With this CE class IIb marking, Posos intends to play a major role in improving the quality and safety of prescriptions across Europe. By facilitating publishers' access to its medical, technological, and regulatory expertise, the medtech enables them to focus on user experience and solution excellence, ultimately providing patients and healthcare professionals with powerful tools for securing the care pathway.
About Posos
Founded in 2018, Posos is a medtech company developing a platform dedicated to optimizing medical prescriptions. Its multilingual medical database and CE class IIb-marked prescription modules are integrated into leading healthcare softwares to help healthcare professionals secure patient care, in compliance with the latest scientific and regulatory recommendations. Posos’ unique offering makes it a reference partner for medical software publishers looking to accelerate their development in Europe. To learn more: https://www.posos.co/
About CE class IIb marking: a mark of excellence that is difficult to obtain
CE class IIb marking applies to medical devices presenting a high risk, such as certain implantable and diagnostic devices. Obtaining it requires a thorough evaluation by a notified body, which verifies compliance with safety and performance requirements defined by European medical device regulations. This long and demanding process requires manufacturers to demonstrate their management system quality, the robustness of their clinical trials, and rigorous risk management. Unlike self-certification possible for class I devices, class IIb devices undergo strict control at each stage of their development and lifecycle.
According to the "Overview of the MD sector in France" study conducted by SNITEM, 51% of companies have considered or triggered marketing discontinuations due to medical device regulations, and 79% have incurred new expenses to comply with the new regulation for products already on the market.