4 common medical device testing questions and how to find balance from an engineering perspective

What Should You Do When a Testing Standard Doesn’t Exist? Part 2: Working through Standards Organizations

In part one of this series, we discussed how medical device technology can frequently outpace the development...

What Should You Do When a Testing Standard Doesn’t Exist? Part 1: Introduction

This is the first part in a six-part series that will help explain your options. When a...

CDRH Science Update: Research Programs Webpages in the Office of Science and Engineering Laboratories at CDRH

The Office of Science and Engineering Laboratories (OSEL)/Center for Devices and Radiological Health (CDRH) is pleased to...

What do you do when regulatory requirements exceed reasonable engineering controls? – Part 4

In part three of this series, we talked about why regulatory requirements for medical device testing might exceed...

What do you do when regulatory requirements exceed reasonable engineering controls? – Part 3

In part two of this series, we talked about why regulatory requirements for medical device testing might...