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
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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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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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FDA Releases Long-Awaited Final Guidance for Clinical Decision Support Software
Published: September 30, 2022
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Digital Health Software Pre-Certification Update: Final FDA Report Revealed
Published: September 28, 2022
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First Manual on Borderline and Classification under MDR Published by the European Commission
Published: September 13, 2022
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MDCG 2022-14: Transition to the MDR and IVDR – Notified Body Capacity and Availability of Medical Devices and IVDs
Published: September 1, 2022
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MDCG 2022-10: Interfaces between the Clinical Trial Regulation and IVDR
Published: August 15, 2022
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