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
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.
Types of clinical studies
There are different types of studies for medical devices. The choice depends on the regulatory status, the stage in the product’s lifecycle, and the type of product. In some cases, different approaches may be considered. Below, we describe the relevant types of studies.
Safety and Performance Based Pathway
The Safety and Performance Based Pathway (SPBP) is a special form of the 510(k) that allows comparison to defined parameters instead of a specific equivalent device. This approach already covers several established and well-understood product types at the FDA.
