FDA Compliance

Filters

Placeholder Image

Will Vaporized Hydrogen Peroxide (VHP) Sterilization for Medical Devices Become More Common?

Published: March 20, 2024

Placeholder Image

Industry Update: Quality Management System Regulation (QMSR)

Published: March 6, 2024

Person analyzing data on dual monitors displaying graphs and charts.

ASCA Accreditation: FDA Annual Report and NAMSA Customer Experience

Published: February 29, 2024

Placeholder Image

Embracing Digital Health Technologies: FDA’s New Guidance for Clinical Trials

Published: February 6, 2024

Placeholder Image

FDA Releases “Predetermined Change Control Plans for Machine Learning – Enabled Medical Devices: Guiding Principles”

Published: October 30, 2023

Placeholder Image

FDA Updates the Recognized Consensus Standards Database with New Sterilization Documents

Published: October 2, 2023

Placeholder Image

FDA Publishes Updated Guidance for Breakthrough Devices Program

Published: September 21, 2023

Placeholder Image

FDA Announces Three New Guidances Dedicated to 510(k) Submissions

Published: September 18, 2023

Placeholder Image

Mechanical Hemolysis Assay for Blood Contacting Devices

Published: September 6, 2023

Placeholder Image

FDA Publishes Notice of Modifications to the Recognized Consensus Standards for Medical Devices

Published: August 15, 2023

Placeholder Image

AI Guidance for Medical Devices | NAMSA

Published: April 3, 2023

Placeholder Image

U.S. FDA Emergency Use Authorization: CRO Lessons Learned for the MedTech Industry

Published: February 8, 2023

Placeholder Image

Health Canada and FDA eSTAR Pilot

Published: January 18, 2023

ISO 10993-18 Primer: Medical Device Chemical Characterization

Published: October 31, 2022

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

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

Understanding the Complex Combination Product Pathway

Published: October 18, 2022

Let’s Talk About Your Project

Ask a question or request a meeting with a NAMSA expert to discuss your specific project. We will follow up as quickly as possible.

First Name*

Last Name/Surname*

Business Email*

Job Title*

Company*

Company Size*

What is the Primary Focus of Your Inquiry?*

We Are Also Interested in Learning More About the Following NAMSA Service (optional)

Where Are You Based?*

Location of Company Office You Work At/Report To*

Zip Code*

How can we help?*

By choosing to submit your information to contact NAMSA, you are providing NAMSA consent to process and store your information on the NAMSA Network. At any time, you can submit a request to withdraw your consent for the use of information provided by you. For additional information, please visit our Privacy Policy.