Regulation of laboratory-developed tests and in-house in vitro diagnostic medical devices in the United States and the European Union—a comparative overview
A Kahles, A-L Volckmar, H Goldschmid, M Salto-Tellez, M Vogeser, J Stone, M Brüggemann, J Budczies, D Kazdal, R Salgado, P Schirmacher, S Peters, JK Lennerz, A Stenzinger · 2025
Read Regulation of laboratory-developed tests and in-house in vitro diagnostic medical devices in the United States and the European Union—a comparative overview by A Kahles, A-L Volckmar, H Goldschmid, M Salto-Tellez, M Vogeser, J Stone, M Brüggemann, J Budczies, D Kazdal, R Salgado, P Schirmacher, S Peters, JK Lennerz, A Stenzinger (2025) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/pmc-12702205.txt.
Description
Process chains in medical diagnostic laboratories lead to an accurate diagnosis and consequently to optimized personalized therapy recommendations. In addition to approved commercial in vitro diagnostic medical devices, devices and tests manufactured and used within a single diagnostic laboratory play a decisive role in these process chains ensuring state-of-the-art diagnostics and consecutive best patient care.
Catalog record
| CREATOR | A Kahles, A-L Volckmar, H Goldschmid, M Salto-Tellez, M Vogeser, J Stone, M Brüggemann, J Budczies, D Kazdal, R Salgado, P Schirmacher, S Peters, JK Lennerz, A Stenzinger |
|---|---|
| YEAR | 2025 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 69 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |