Regulatory

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Pacemaker Lead Device Testing

Published: February 1, 2024

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Preclinical, Clinical and Testing Expertise for Heart Valves

Published: February 1, 2024

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Navigating the Transition: Understanding the EU’s Proposed Amendments to IVDR

Published: January 29, 2024

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EN 13726 Updates: Assessing Wound Dressing Performance

Published: January 16, 2024

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ISO 10993-17:2023 Update: Key Changes and FDA Recognition

Published: January 4, 2024

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MDCG 2021-6 Rev 1: Clarifications on Clinical Investigations

Published: December 20, 2023

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European Heart Journal: Randomized Controlled Trials Are Not Always the Solution

Published: December 13, 2023

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MDCG 2022-11 Rev 1: Urgency for MDR and IVDR Compliance

Published: December 4, 2023

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Five Reasons Not to Delay Your MDR Certification

Published: December 1, 2023

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Why IVD Developers Must Embrace the IVDR Transition Now

Published: November 21, 2023

What is an EDC System and How Does it Support Clinical Trials?

Published: November 7, 2023

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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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