Generation of clinical data on the safety and performance of medical devices through clinical research in accordance with the current and future legislation

Autor:	Mijo Bozic, Hans P Zenner, Gerald G. Sander
Rok vydání:	2020
Předmět:	Gynecology medicine.medical_specialty Philosophy medicine General Medicine
Zdroj:	Zeszyty Naukowe Państwowej Wyższej Szkoły Zawodowej im. Witelona w Legnicy. 4:11-19
ISSN:	2449-9013 1896-8333
DOI:	10.5604/01.3001.0014.7376
Popis:	In this paper, the authors provide a quick overview of current and future legislation operating in Germany and the European Union which regulates clinical research into medical devices intended for human use. It also briefly discusses the importance of data protection provisions and the relevance of international standards and guidelines for proper performance of clinical research.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::26833f218c9c2f0378f88a9793576c06 https://doi.org/10.5604/01.3001.0014.7376 Zobrazit plný text záznamu