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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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Medical Device Packaging Validation: 5 Testing Best Practices for 2023

Published: September 14, 2023

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Mechanical Hemolysis Assay for Blood Contacting Devices

Published: September 6, 2023

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How ISO 10993-17:2023’s Toxicological Screening Limit Can Change the Game for Medical Device Manufacturers

Published: August 18, 2023

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

Published: August 15, 2023

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

Published: July 26, 2023

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Medical Device Commercialization Process: Q&A

Published: July 19, 2023

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Clinical Trial Cost Analysis with Site Budget Estimates

Published: July 12, 2023

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How the Updated ISO 10993-17:2023 Could Change Toxicological Risk Assessment

Published: June 29, 2023

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Your Guide to Biostatistics Outsourcing and Consulting

Published: May 3, 2023

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Using High Resolution Gas Chromatography to Keep Costs in Control While also Protecting Patients

Published: April 10, 2023

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