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FDA Releases New Draft Guidance for Biocompatibility of Devices in Contact with Intact Skin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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Developing Cleaning Methods for Successful Validation
Published: October 12, 2020
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The Facts About In Vitro Irritation
Published: September 30, 2020
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ISO 10993-4: The Second Most Misunderstood Section of 10993
Published: August 26, 2020
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Key Considerations for Executing Clinical Trials for Dual 510(k) and CLIA Waiver Applications
Published: August 11, 2020
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AATCC TM 100-2019: Assessment of & What It Means for Medical Textiles
Published: July 30, 2020
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FDA and ISO 10993-18:2020
Published: July 21, 2020
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Listener MailBag – We Answer Your Questions
Published: July 21, 2020
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The Secret Recipe for Testing Success
Published: July 13, 2020
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The IVDR Compliance Roadmap: From Start to Finish
Published: July 8, 2020
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