17 Sep, 2023 Lifecycle Processes, Regulatory Affairs Update: The English Way – aka “UK MDR 2002 by seleon
07 Aug, 2023 Clinical Affairs, Clinical Affairs, Regulatory Affairs, Regulatory Affairs Claims Management and IFU Compliance by Hinsija Schilling
21 Jul, 2023 Clinical Affairs, Regulatory Affairs Established in vitro diagnostics in further use by Hinsija Schilling
31 May, 2023 Health Software, Regulatory Affairs When is my software considered a medical device and what class is it? by Hinsija Schilling
31 May, 2023 Regulatory Affairs “Combination products” and their regulatory requirements by Hinsija Schilling
28 Apr, 2023 Regulatory Affairs, Regulatory Affairs The translation dilemma – Intended use vs. intended purpose 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