Coming soon
Krevyos Medical Devices
Medical devices and diagnostics
The technical file lives where the operation lives.
MDR and IVDR in the EU, 510(k) and PMA in the US, equivalents in Japan, China, and Brazil: each demands a technical file, a clinical evaluation, and a post-market surveillance system that have to stay in sync as the device evolves. Most operations stretched pharma tools to cover the gap. Krevyos Medical Devices holds the device dossier on the same data layer as the rest of Krevyos, so a design change reaches every regulatory and clinical artifact that depends on it.
Krevyos Medical Devices is not yet in development.
Krevyos Generics is the product available today, in early access.