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MDCG 2023-4: Medical Device Software (MDSW) – Hardware Combinations

Published: November 1, 2023

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FDA Releases “Predetermined Change Control Plans for Machine Learning – Enabled Medical Devices: Guiding Principles”

Published: October 30, 2023

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ANSI/AAMI ST98: A Guideline for Cleaning Validations of Reusable Devices

Published: October 10, 2023

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FDA Updates the Recognized Consensus Standards Database with New Sterilization Documents

Published: October 2, 2023

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FDA Publishes Updated Guidance for Breakthrough Devices Program

Published: September 21, 2023

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FDA Announces Three New Guidances Dedicated to 510(k) Submissions

Published: September 18, 2023

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Mechanical Hemolysis Assay for Blood Contacting Devices

Published: September 6, 2023

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FDA Publishes Notice of Modifications to the Recognized Consensus Standards for Medical Devices

Published: August 15, 2023

5 Steps for A Successful Medical Device Go-To-Market Strategy

Published: July 26, 2023

Medical Device Commercialization Process: Q&A

Published: July 19, 2023

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AI Guidance for Medical Devices | NAMSA

Published: April 3, 2023

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U.S. FDA Emergency Use Authorization: CRO Lessons Learned for the MedTech Industry

Published: February 8, 2023

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Health Canada and FDA eSTAR Pilot

Published: January 18, 2023

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MDR Update: EPSCO Proposes Transition Improvements and EU Commission Issues MDCG 2022-18

Published: December 16, 2022

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EU Commission Publishes MDR Implementing Regulation for Devices without Medical Purpose (Annex XVI)

Published: December 6, 2022

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Auditing a QMS According to ISO 13485

Published: November 28, 2022

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