The objective is to ensure the recertification of the Predict4Health SMQ, whose mission is to help make clinical decisions using AI in the organ transplantation sector. They developed the Predigraft platform, equipped with iBox technology: the first universal predictive algorithm for transplantation, qualified as a surrogate biomarker by the European Medicines Agency.
Context
Okeiro has developed a certified class IIa digital medical device (DMN) software suite under MDR. The software developed allows the realization of predictions of the diagnosis of graft rejection using prognostic scores, and the virtualization of certain invasive medical examinations. The main algorithm, iBox, is qualified by the European Medicines Agency as a surrogate biomarker in the context of clinical trials, allowing the reduction of the time (and costs) of these studies. To maintain its ISO 13485 certification, Okeiro must pass an audit of its QMS by a notified body.
Challenges
- Ensure the recertification of Okeiro on the ISO 13485 standard
- Close the NCs and CAPAs opened since the last audit before the new audit
- Train teams to prepare a technical file for the two class IIA medical devices
Our approach
A team of 2 Theodo regulatory experts (quality director and QARA) to update the documentation and close the NCS/CAPAs.
What made the difference:
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Learning organization
Internal QARA training in compiling a technical file and maintaining a QMS.
Just in Tima
Like a development project, teams were organized into one-week sprints with previously defined deliverables. Our entire regulatory roadmap was based on that of the client-side product: we took into account all their constraints and dependencies, to ensure the delivery of the necessary documents according to the product's milestones.
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Value for customer
Our regulatory expert participated in the audit conducted by BSI during which only 6 minor CNs were identified and recertification ensured.
“We are very happy with the proposals made by the Theodo team. We have been fully recertified, it has been a real success! We were able to benefit from all the expertise and field experience of the teams, as well as from very reactive and agile support. Everything is going very fast, and it's great to have daily reports to follow up on.”
