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MDCG 2021-6 Rev 1: Clarifications on Clinical Investigations

Posted 11 months ago

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

Posted 11 months ago

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Talking Risk with Dr. Naveen Agarwal-Part 2

Posted 11 months ago

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Preclinical Considerations: Testing Regulated Wound Healing Devices

Posted 11 months ago

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

Posted 11 months ago

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Five Reasons Not to Delay Your MDR Certification

Posted 11 months ago

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Talking Risk with Dr. Naveen Agarwal-Part 1

Posted 12 months ago

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Why IVD Developers Must Embrace the IVDR Transition Now

Posted 1 year ago

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WOUNDS UK: Models and Methods to Support the Development of Novel Burn Wound Antimicrobial Treatments

Posted 1 year ago

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Chemistry with the MFDS

Posted 1 year ago

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

Posted 1 year ago

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

Posted 1 year ago

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

Posted 1 year ago

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Trends in MedTech Outsourcing

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

Posted 1 year and 1 month ago

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New FDA Biocompatibility Guidance – Let’s Discuss

Posted 1 year and 1 month ago

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