novineon - working regulatory wonders!
For more than two decades, novineon CRO has been a leading service provider supporting manufacturers of medical devices and in vitro diagnostics on their path to market success. In our work, we combine profound regulatory knowledge with scientific precision – exactly what manufacturers need to meet the complex requirements of the medical technology industry.
We understand the challenges in developing and assessing conformity of medical devices and beyond. From defining the intended purpose to creating clinical evaluations and conducting clinical studies, we offer tailored solutions for your specific device.
For manufacturers with international ambitions, we efficiently support the approval process in the USA, Canada, and other markets in South America and Asia. By intelligently linking European and international approval strategies, we optimize your resources and significantly accelerate market access.
We also offer comprehensive support for manufacturers of in vitro diagnostics with the special regulatory requirements of the IVDR.
Your medical device deserves experts who speak your language. Together, we transform regulatory hurdles into milestones on your path to success.
Clinical Evaluation
Clinical Evaluation by Experts: Systematic, Comprehensive, Appropriate for Your Device
Clinical Affairs
Discover Further Services in Clinical Affairs: Including Post-Market Surveillance, Risk Management, Biological Evaluation
International
International Product Registrations and Approvals: USA, Canada and Other Markets
Clinical Studies
Full Service: From Study Concept to Scientific Publication
IVD
Clinical Evidence - Get to the Core of it with Experitise and Experience
Together more than
years working experience
Projects in more than
different countries
More than
projects with class III devices
Client satisfaction mark
in the last year
MDCG 2025-9 Guidance on Breakthrough Devices (BtX)
The MDCG 2025-9 Guidance outlines the regulatory framework for breakthrough devices (BtX) under the European Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). Its main goal is to enable timely patient access to innovative devices that address serious, life-threatening, or irreversibly debilitating conditions, without compromising the clinical evidence requirements for these devices. The guidance applies to all technologies and risk classes, except for custom-made devices, in-house devices, and products without a medical purpose.
Read more … MDCG 2025-9 Guidance on Breakthrough Devices (BtX)
Status Quo in Clinical Investigations of Medical Devices: Experience with Requirements, Implementation and Opportunities
Dr. Sabrina Rohrer, Head of Clinical Studies at novineon, and Carolin Kurth, Founder and Managing Director of Camovis GmbH, have jointly published a comprehensive technical article in the Medizinprodukte Journal. Across 9 pages, the authors combine well-founded aspects of regulatory legislation with valuable experience from practical implementation.
Milestones on the road to clinical evaluation
According to the MDR, the clinical evaluation should be appropriate to the product, taking into account its characteristics and intended purpose. But what does 'appropriate' mean, and when is the data 'sufficient'? This article describes the six milestones for a successful clinical evaluation.
