Welcome to Valnizen - Your Trusted Source for
20+ Years of Expertise
Valnizen as Medtech CRO
The Med-Tech Industry’s go-to-market timing is five times faster than drug development. So medical device Industries or start up need a med-tech CRO partner who has expertise in the field, who understands the differences between the go to market process of pharmaceutical, medical device and diagnostic and guide them the appropriate routes to market with the required regulatory framework.
In the past years we worked on an array of different types medical devices, In-Vitro Diagnostics, and digital health products, requiring market approvals via FDA, 510(k), HDE, CE mark or PMA, IDE.
We are unparallelly fast in understanding the MedTech landscape which help our customer to reach their end mile through regulatory, planning, and clinical trials of their product.
From consultation to commercialization, at each step Valnizen Healthcare will be there to promote your growth by setting up and managing MedTech projects, from ISO 13485/15189 certification to IVDR/MDR technical file development, as well as the design and management of clinical studies for CE Marking or FDA approval.
Mission
Our mission is to contribute in health and safety of patients by supporting the advancement of biomedical technology. We are committed to support medical device and in-vitro diagnostics manufacturers, MedTech startups, Small and mid-size companies by providing them high-quality, affordable Clinical Trial Services, Regulatory support, medical device approvals and market access for achieving and maintaining regulatory compliance.
Vision
Our Vision is to be the world’s most trusted clinical trial and regulatory partner for medical device companies by providing a high standard of quality, competence and customer service, for building towards a better future
Focus Areas
Specializing in a wide range of focus areas to provide innovative solutions and expert support for your MedTech projects
Cardiovascular
Orthopedics
Neuromodulation
Oncology
General Surgery
IDV(In-Vitro Diagnostics)
SaMD(Software as Medical Devices)
