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Month: April 2021

FDA Qualifies New Cybersecurity Medical Device Development Tool

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On October 20, 2020, the U.S. Food and Drug Administration’s (FDA) Medical Device Development Tools (MDDT) Program announced the qualification of a new tool for medical device development within cybersecurity risk evaluations.

MDCG Publishes New Guidance on Use of Standards Under MDR/IVDR

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On April 16, 2021, the Medical Device Coordination Group (MDCG) published “Guidance on Standardisation for Medical Devices” (MDCG 2021-5).