Veranex neemt Devicia en Clarvin over, waardoor de regelgeving, kwaliteit en klinische expertise voor IVD en medische hulpmiddelen wordt uitgebreid
RALEIGH, N.C.–(BUSINESS WIRE)– Veranex, de enige echt uitgebreide, wereldwijde, door technologie ondersteunde dienstverlener die zich toelegt op de medische technologie-industrie, heeft vandaag aangekondigd dat het een ecosysteem van full-service consultancybedrijven voor medische hulpmiddelen heeft verworven, die regelgevende en klinische zaken, kwaliteitsborging en bio compatibiliteit diensten voor medische hulpmiddelen en hulpmiddelen voor in-vitrodiagnostiek (IVD). Dit ecosysteem, gevestigd in Zweden, omvat Devicia, een full-service partner die klinische expertise biedt; Clarvin, een aanbieder van strategische begeleiding bij regelgevende zaken en kwaliteitsborging; en gelieerde bedrijven Kickfile, Lea Reg en Limulus Bio. Samen met de recente acquisitie van het in Zwitserland gevestigde Medidee, breiden deze bedrijven het Europese bereik van Veranex verder uit en bouwen ze regelgevende, klinische en kwaliteitsservicesegmenten op. Dit versterkt specifiek de strategie voor de regelgeving voor medical device regulation (MDR) en in vitro diagnostic regulation (IVDR) van Veranex, door expertise in biologische evaluaties en software voor medische hulpmiddelen toe te voegen en de infrastructuur uit te breiden en lokale vertegenwoordiging in de Europese Unie en het Verenigd Koninkrijk aan te wijzen.
Veranex Acquires Devicia and Clarvin, Expanding Regulatory, Quality, and Clinical Expertise for IVD and Medical Devices
RALEIGH, N.C.–(BUSINESS WIRE)– Veranex, the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry, announced today that it has acquired an ecosystem of full-service medical device consultancy companies, providing regulatory and clinical affairs, quality assurance, and biocompatibility services for medical devices and in vitro diagnostic (IVD) devices. 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,” said Veranex CEO David Dockhorn. “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 U.S. 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,” said Devicia CEO Elisabeth Liljensten.
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 (MWE) 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. Financial details are not being disclosed.
About Veranex
Veranex is the only truly comprehensive, 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. For more information, visit VeranexSolutions.com and follow on LinkedIn.
About Devicia
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 their vast experience and participation on technical committees – they provide their clients with an informed perspective.
About Clarvin
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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