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Why Biocompatibility Cares about Preclinical: NAMSA and APS Discuss
Published: March 24, 2021
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When to Go with In Vitro: Your Irritation Questions Answered
Published: February 23, 2021
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Effective March 15: CMS Rule Regarding Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’
Published: February 8, 2021
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3 Regulatory Red Flags with Medical Device Changes
Published: January 28, 2021
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Is your Biocompatibility Program Knocking your Submission Off Track?
Published: January 27, 2021
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U.S. FDA Releases Artificial Intelligence and Machine Learning Action Plan
Published: January 18, 2021
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U.S. FDA Introduces Safer Technologies Program to Promote Safe, Early Access to Innovative Medical Devices
Published: January 12, 2021
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Oh No, Another Failed Cyto!
Published: December 23, 2020
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Intact Skin Contact Devices: To Test or Not to Test
Published: November 25, 2020
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New Guidance: Classification of IVD under the IVDR
Published: November 24, 2020
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Preparing for a Pre-Submission Meeting En Route to Regulatory Approval
Published: November 3, 2020
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Behind the Curtain: How ISO 10993 Impacts Testing Labs
Published: November 2, 2020
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What in the World is the FDA’s Lab Accreditation Program – ASCA?
Published: October 28, 2020
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Preparing Biocompatibility Risk Assessments for International Registration
Published: October 26, 2020
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FDA Releases New Draft Guidance for Biocompatibility of Devices in Contact with Intact Skin
Published: October 19, 2020
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Responding to Regulatory Requests for Additional Information
Published: October 16, 2020
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