Medical Device Testing

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Scientist in lab coat and blue cap using a microscope in a laboratory, illustrating NAMSA's biocompatibility testing capabilities.

How ISO 10993-17:2023’s Toxicological Screening Limit Can Change the Game for Medical Device Manufacturers

Published: August 18, 2023

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

How the Updated ISO 10993-17:2023 Could Change Toxicological Risk Assessment

Published: June 29, 2023

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Blue-gloved hands using a pipette to work with pink laboratory tubes.

Using High Resolution Gas Chromatography to Keep Costs in Control While also Protecting Patients

Published: April 10, 2023

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ISO 10993-18 Primer: Medical Device Chemical Characterization

Published: October 31, 2022

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Person wearing gloves and mask using a microscope in a brightly lit lab, illustrating NAMSA's microbiology testing capabilities

Why Complete Chemical Characterization Matters for Plastics

Published: October 18, 2022

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Scientist in a lab coat using a pipette in a laboratory setting.

Understanding the Complex Combination Product Pathway

Published: October 18, 2022

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Person using a white microscope in a lab with blue-lit screens in the background.

ISO 10993-1 Primer: Medical Device Testing for Risk Management

Published: July 13, 2022

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Overcoming Obstacles to Tissue Sterilization Validation: What Manufacturers Need to Know

Published: February 21, 2022

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Are You Prepared If Your Disinfectant Is Discontinued?

Published: November 8, 2021

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Lab setup with pipette and COVID-19 test kit, illustrating NAMSA's medical research.

Regulatory Development Indicates Shift Toward In Vitro

Published: July 30, 2021

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A rare disease patient filling out an online survey on a laptop.

What to Ask Before Submitting Your Medical Device for Approval

Published: June 7, 2021

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Scientist in a lab wearing goggles and purple gloves using a pipette representing NAMSA's biological safety consulting service

Packaging Pitfalls Medical Device Manufacturers Cannot Ignore

Published: May 13, 2021

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3 Regulatory Red Flags with Medical Device Changes

Published: January 28, 2021

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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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