28 Apr, 2023 Regulatory Affairs, Regulatory Affairs The translation dilemma – Intended use vs. intended purpose by Hinsija Schilling
13 Mar, 2023 Regulatory Affairs, Regulatory Affairs Technical documentation – international concepts for demonstrating safety and performance by Hinsija Schilling
03 Mar, 2023 Regulatory Affairs The MDR (EU) 2017/745 and its 2023 deadline amendments by Hinsija Schilling
03 Feb, 2023 Clinical Affairs, Regulatory Affairs Periodic Safety Update Report after 2 years MDR by Hinsija Schilling
20 Dec, 2022 Regulatory Affairs Artificial Intelligence Basics for medical technology by Hinsija Schilling
21 Oct, 2022 Regulatory Affairs Testing for cytotoxicity: The “well-established” EN ISO 10993-5 by Alexandra Grosu
17 Aug, 2022 Regulatory Affairs Electronic instructions for use – The hidden duty of MDR by seleonadmin
