Standards & Guidance

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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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Doctor types on laptop next to a stethoscope on a desk.

Safe & Compliant: Mitigating Risks After Device Modifications

Published: May 4, 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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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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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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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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