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Deal expands Veranex's regulatory, quality, and clinical expertise for IVD and medical devices.
November 8, 2022
By: Michael Barbella
Managing Editor
Veranex has expanded its geographic and professional capabilities footprint with the purchase of several full-service medical device consultancy companies that provide regulatory and clinical affairs, quality assurance, and biocompatibility offerings for medical devices and in-vitro diagnostic (IVD) products. Terms of the deal were not disclosed. Based in Sweden, this ecosystem includes Devicia, a full-service partner offering clinical expertise; Clarvin, a provider of strategic guidance in regulatory affairs and quality assurance; and affiliate companies Kickfile, Lea Reg, and Limulus Bio. Together with the recent acquisition of Swiss-based Medidee, these companies further expand Veranex’s European reach and build regulatory, clinical, and quality service segments. This specifically strengthens Veranex’s medical device regulation (MDR) and in-vitro diagnostic regulation (IVDR) strategy, adding expertise in biological evaluations and medical device software and expanding infrastructure and designating local representation in the European Union and United Kingdom. “This group of companies, led by Devicia and Clarvin, shares the same goal as Veranex: working with our clients to achieve and accelerate MedTech innovation,” Veranex CEO David Dockhorn said. “Devicia, Clarvin, and their affiliate companies all focus exclusively on medical devices and IVD, providing strategic guidance and informed execution across a number of areas, including clinical trial, medical writing, regulatory strategies, toxicology assessments, designated local representation, and system technologies that bolster Veranex’s full-service MedTech capabilities and solutions.” The group of companies adds three locations across Europe and the United States to Veranex’s global footprint. “We are extremely excited about the opportunity to support clients even more comprehensively with our full-service medical device and IVD services, and a significantly stronger global presence. We strongly believe that a global perspective and broad geographic footprint provides strategic value to market access for our clients,” Devicia CEO Elisabeth Liljensten said. Clarvin CEO Åsa Runnäs added, “Since the first interaction with Veranex, we realized we shared the same vision for the best way to help our clients—with a combination of top regulatory intelligence, expert knowledge within different areas, and true global reach.” Alvarez & Marsal (A&M) served as financial advisor and McDermott Will & Emery served as legal advisor to Veranex on this transaction. Christopher Fägerskiöld AB served as financial advisor and Kanter as legal advisor to Devicia and Clarvin group. Veranex is a global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept to commercialization and across the development continuum, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex customers realize efficiencies in cost and time, while its comprehensive solutions unify and streamline the entire development process. Veranex is backed by Summit Partners, Accelmed, and Lauxera Capital Partners. Devicia is a full-service consulting firm offering clinical expertise for medical devices, supporting clients throughout the life cycle of medical device and IVD. With advice that is always founded on its experience and participation on technical committees the company provides clients with an informed perspective. To medical device and IVD manufacturers, Clarvin is the regulatory consultant that guides and supports in every aspect of regulatory affairs and quality assurance processes. The team of experts identifies customized regulatory intelligence solutions within rapidly emerging technologies and the evolving regulatory landscape.
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