Evidence Partners, developer of AI-enabled literature review automation software and creator of DistillerSR, has announced a collaboration with Akra Team, a German-based strategic regulatory consultancy, to deliver end-to-end consulting services that make it easier and faster for medical device companies to complete EU MDR and IVDR notified body submissions. The partnership brings together DistillerSR and the Akra Team’s strategic regulatory services to deliver standard operating processes and workflows to improve the management of regulatory risk, literature reviews and submissions for different device types.
Headed by Dr. Bassil Akra, Akra Team provides strategic consulting services to global companies manufacturing medical and in-vitro diagnostic devices, as well as notified bodies and industry regulators. DistillerSR automates the management of literature collection, triage and assessment using AI and intelligent workflows to reduce the time it takes to complete a systematic literature review.
“Medical device and in-vitro diagnostic device manufacturers are facing tremendous hurdles in securing timely regulatory approvals for their products in the EU,” said Peter O’Blenis, CEO of Evidence Partners. “This new combined offering gives regulatory teams a more efficient toolkit to create and maintain their regulatory dossiers while also providing the confidence that their submissions will not be held up in audits.”