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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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New Guidance: Classification of IVD under the IVDR

Published: November 24, 2020

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Two people discussing documents at a wooden table with a laptop and calculator.

Preparing for a Pre-Submission Meeting En Route to Regulatory Approval

Published: November 3, 2020

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Pipette drops liquid into test tubes with yellow and blue lighting.

Behind the Curtain: How ISO 10993 Impacts Testing Labs

Published: November 2, 2020

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Scientist points at mass spectrometry analysis on a computer screen in a lab representing NAMSA's extractables and leachables testing capabilities using chemical characterization

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FDA Releases New Draft Guidance for Biocompatibility of Devices in Contact with Intact Skin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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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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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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Streamlining Submissions with Product Adoption for Radiation Sterilization

Published: June 11, 2020

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Clinical research specialist at microscope, symbolizing advanced medical testing expertise.

Stop Letting GLP Stunt Your Chemistry Studies

Published: June 11, 2020

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FDA Releases Final Guidance on Bone Anchor Premarket Notification 510(k) Submissions

Published: March 5, 2020

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Preparing for MDR: Don’t Forget About Class I Reusable Devices

Published: February 18, 2020

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