As a trusted European regulatory and quality service consultancy joining Veranex, Medidee expands and strengthens regulatory affairs, clinical development, and quality assurance services and capabilities for MedTech companies across Europe and the world. This improved ability to navigate the European Union’s Medical Device and In Vitro Diagnostic Device Regulations (EU-MDR/IVDR) challenges supports truly full-service MedTech product development and commercialization.
“Our acquisition of Medidee significantly expands our European footprint while also materially expanding the scale and scope of the clinical studies we can manage,” said Veranex CEO David Dockhorn. “The combined organization offers offices and expertise across Europe, the U.S., and Asia, augmenting our ability to help MedTech innovators achieve FDA and CE Mark approvals and uninterrupted market access for new as well as proven medical technologies that advance patient care.”
With Medidee’s 11 locations across Europe, India, and Asia-Pacific, and Veranex’s 13 locations across the U.S., Europe, and China, the company now has unprecedented reach to serve clients with a full spectrum of integrated concept-to-commercialization services — design, engineering, regulatory, quality, preclinical research, clinical development, clinical operations, commercial strategy, and market access services — all under one umbrella. Medidee is one of the Top 3 medical device consultancy service providers in Europe uniquely positioned as a leader in future key areas such as digital health, machine learning, and cybersecurity. The company also brings expertise in clinical research exclusively focused on medical devices and in vitro diagnostics.
“Medidee has a proven track record serving regulatory, clinical, and quality needs for companies of all sizes, with consulting expertise and clinical trial support in increasingly diverse therapeutic areas and technology categories across multiple geographies,” shared Medidee co-founders Kim Rochat, Philippe Etter, and Michael Maier. “With these services, coupled with the global infrastructure of Veranex, we expand expertise and resources for the benefit of our clients as well as for all EU innovative manufacturers wishing to access rapidly and efficiently the U.S. market and beyond. We look forward to providing these additional strengths and capabilities,” added the co-founders who take on new roles in the combined organization.
Raymond James Financial, Inc. (NYSE: RJF) served as an advisor to Medidee for this transaction. Financial details are not being disclosed.
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 Medidee Services
Medidee was established by three partners, all experts in the field of medical devices. With 50 experts in all fields necessary to ensure compliance with the most stringent requirements, Medidee provides the necessary competencies to ensure and demonstrate compliance with all key medical device regulations. Medidee expends regularly to provide the best resources and competencies and supports more than 350 manufactures all over the world.