Standards & Guidance

Filters

Microchip with shield icon; digital circuit background, blue light highlighting connections.

FDA Premarket and Postmarket Medical Device Cybersecurity

Published: March 26, 2025

View

Healthcare professional in blue scrubs leading a meeting with diverse colleagues.

A Guide to ISO 10993-18’s Analytical Evaluation Threshold

Published: November 21, 2024

View

Medical professionals in blue scrubs and white coats collaborating, with a laptop.

Enhancing Chemical Characterization with the CLAP Database

Published: November 14, 2024

View

Person holding a pink petri dish and a blue tool, wearing blue gloves. Illustration of NAMSA's sterility testing services.

2 Regulatory Standards That Ensure Medical Devices are Transported and Stored Safely

Published: October 3, 2024

View

Understanding the ISO 18562:2024 Standards Update for Medical Devices

Published: April 17, 2024

View

European Union blue flag with yellow stars waving in the wind, symbolizing NAMSA's work consulting on European Union medical device regulations

What Manufacturers Need to Know About the MDR Deadline Extension

Published: April 5, 2024

View

Understanding ‘Assumed Release’ in ISO 10993-17:2023

Published: April 5, 2024

View

What Could a PFAS Phase-out Mean for Medical Product Manufacturers?

Published: April 5, 2024

View

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

Beyond Standard Testing: Exploring the Benefits of Custom Preclinical Solutions

Published: April 5, 2024

View

MDCG 2024-2: Procedures for the Updates of the European Medical Device Nomenclature

Published: March 13, 2024

View

European Commission Updates Chemical Classification and Labeling

Published: February 2, 2024

View

EN 13726 Updates: Assessing Wound Dressing Performance

Published: January 16, 2024

View

ISO 10993-17:2023 Update: Key Changes and FDA Recognition

Published: January 4, 2024

View

WOUNDS UK: Models and Methods to Support the Development of Novel Burn Wound Antimicrobial Treatments

Published: November 16, 2023

View

Navigating Cytotoxicity Failures in Medical Devices: Comprehensive Risk Management Strategies

Published: November 3, 2023

View

ANSI/AAMI ST98: A Guideline for Cleaning Validations of Reusable Devices

Published: October 10, 2023

View

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*

Where Are You Based?*

What is the Primary Focus of Your Inquiry?*

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.