13 Sep, 2024 Lifecycle Processes, Regulatory Affairs The new Packaging and Packaging Waste Regulation – how will medical devices be packaged in future? by Hinsija Schilling
02 Aug, 2024 Lifecycle Processes, Sustainability, Regulatory Affairs, Sustainability A new EU Parliament – A new EU Green Deal? by Hinsija Schilling
10 May, 2024 Lifecycle Processes Sustainability as a challenge for medical technology? by Hinsija Schilling
22 Mar, 2024 Lifecycle Processes, Regulatory Affairs Part 820 – the FDA is changing its QM requirements as of 2026 by Hinsija Schilling
05 Mar, 2024 Clinical Affairs, Lifecycle Processes, Regulatory Affairs, Software Filling gaps instead of turning loops by Hinsija Schilling
12 Jan, 2024 Lifecycle Processes, Lifecycle Processes, Regulatory Affairs, Regulatory Affairs Risk management according to ISO 14971:2019 – what’s new? by seleon
14 Dec, 2023 Lifecycle Processes Machinery Regulation – designed for the future. For your medical device too? by Hinsija Schilling
12 Oct, 2023 Lifecycle Processes, Lifecycle Processes, Regulatory Affairs, Regulatory Affairs Risk-based approach and statistical methods in process validation by Hinsija Schilling
17 Sep, 2023 Lifecycle Processes, Regulatory Affairs Update: The English Way – aka “UK MDR 2002 by seleon
