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
18 Jan, 2024 Regulatory Affairs, Regulatory Affairs Common Specifications addressing Annex XVI Devices by Hinsija Schilling
13 Jan, 2024 Regulatory Affairs, Regulatory Affairs Technical documentation – international concepts for demonstrating safety and performance by Hinsija Schilling
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
09 Oct, 2023 Regulatory Affairs MDCG Guidance Documents – Guidance documents for every topic by Hinsija Schilling
