Resource Library

Filters

Placeholder Image

EMA Issues Q&A Regarding Impact of MDR, Article 117

Published: March 6, 2019

Placeholder Image

Effective Implementation of EN ISO 14971 Medical Device Risk Management Standard

Published: August 15, 2018

Placeholder Image

FDA Issues New Draft Guidance Document for Pre-Submissions

Published: June 11, 2018

Placeholder Image

CE Marking of Digital Health Technologies: Stricter Rules for Medical Device Software under the EU MDR

Published: April 24, 2018

Placeholder Image

Obtaining Actionable FDA Feedback: How to Develop Targeted Questions for Pre-Submission Meetings

Published: January 23, 2018

Placeholder Image

ISO 13485:2016 – Effective Preparation and Implementation of Medical Device Quality Management Systems

Published: January 8, 2018

Placeholder Image

The Importance of Human Factors & Usability Engineering in Medical Devices

Published: October 9, 2017

Placeholder Image

Utilizing Biological Risk Assessments and Chemical Characterization to Reduce Medical Device Development Timelines

Published: September 27, 2017

Placeholder Image

The Value of Randomized Pilot Studies in Demonstrating Patient Safety and Efficacy

Published: August 30, 2017

Placeholder Image

Risk: An Emerging Driver for New Regulatory Requirements

Published: June 15, 2017

Placeholder Image

Why Regional Reimbursement Strategies Could Be Right For Medtech

Published: March 30, 2017

Placeholder Image

FDA Clarifies Policy for Color Additives in Medical Devices

Published: April 11, 2016

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. Also, please tell us how you heard about NAMSA.

First Name*

Last Name/Surname*

Business Email*

Company*

Where Are You Based?*

Location of Company Office You Work At/Report To*

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 or contact us at privacy@namsa.com.