AI/ML Enabled Medical Devices
An archived Enerxen overview of AI/ML-enabled medical devices, FDA considerations and lifecycle approaches, originally published in January 2024.
Read article →Enerxen insights
Ideas, context,
and practical perspective.
Perspectives on medical device regulation and quality, from our team. Articles are available in English.
Software Security Standards
An archived overview of medical device software security standards and FDA recognition, with links to the original references. Published in November 2023.
Read article →CE Marking
An archived introduction to CE marking for medical devices, the European regulatory framework and conformity assessment, published in November 2023.
Read article →CDRH: Updated Draft Guidances – 510(k) Program
Enerxen’s archived 2023 review of CDRH draft guidance updates for the FDA 510(k) program, including key themes and reference links.
Read article →Medical Device Software Guidance
An archived Enerxen overview of FDA guidance for medical device software and hardware combinations, originally published in October 2023.
Read article →“Regression Analysis”, How to test for unintended consequences in your corrective actions
Explore Mauricio Rodriguez’s article on assessing unintended consequences when corrective actions affect medical device design, specifications and validation.
Read article →What’s inside of FDA QSR Subpart 820.100(a)(4)?
Read Mauricio Rodriguez’s archived discussion of CAPA verification of effectiveness, design changes and FDA Quality System Regulation. Published in July 2020.
Read article →The New EUMDR in a Nutshell
Read Enerxen’s archived 2020 introduction to the EU Medical Device Regulation, including clinical evidence, post-market surveillance and documentation.
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