22 Mar, 2024 Lifecycle Processes, Regulatory Affairs Part 820 – the FDA is changing its QM requirements as of 2026 by Hinsija Schilling
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18 Jan, 2024 Regulatory Affairs, Regulatory Affairs Common Specifications addressing Annex XVI Devices by Hinsija Schilling
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13 Jan, 2024 Regulatory Affairs, Regulatory Affairs Technical documentation – international concepts for demonstrating safety and performance by Hinsija Schilling
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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