Evidence Partners® Inc., a market leader in AI-enabled literature review automation software and creator of DistillerSR™, 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 that 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. Dr. Akra is a recognized industry expert in preparing medical, in-vitro diagnostic and combination device companies for compliance with the EU MD and IVD regulations. 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. Global top 10 medical device companies using DistillerSR are reporting dramatic reductions in the time required to screen scientific literature. One top five global medical device company, for example, reduced its screening time by 70 percent.
“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. With so much at stake, our collective service provides a hyper-charged pathway to help our customers get their submissions right the first time, by integrating market-leading regulatory expertise and DistillerSR as the best-of-breed literature review platform.”
“The industry needs an integrated suite of strategic regulatory services anchored by DistillerSR to ensure all the critical submission requirements are met in a clearly auditable business process,” said Dr. Akra, CEO of Akra Team. “Adherence to EU MD and IVD regulatory environments enables organizations to scale and manage submissions for other markets, such as Japan, with similar rigorous requirements.”
Literature reviews are a cornerstone of evidence-based research, but their production has traditionally been difficult, time consuming and error prone. More than 300 of the world’s leading research organizations, including more than 50 percent of the largest pharmaceutical and medical device companies, trust DistillerSR to securely produce transparent, audit-ready and regulatory compliant literature reviews faster and more accurately than any other method. As a result, healthcare researchers can make more informed and time-sensitive health policy decisions, clinical practice guidelines and regulatory submissions.