Medical device manufacturers are well aware of the benefits cellular technology can bring to their products. A cellular link, for example, can send patient data off-site to enable remote monitoring. Although cellular technology adds exciting new possibilities for healthcare, it also adds regulatory burdens. Often, a manufacturer considers adding wireless in dozens of countries but ultimately proceeds with only a few.
In this white paper you learn about the steps a company should consider before marketing their wireless medical device in international markets, and offers a window into how product approvals vary around the world.
- Will you need to provide samples and how many?
- Testing considerations - what happens if the testing fails?
- Making your engineers available to speak to test engineers
- The need for bilingual partners for your international markets
Example situations are presented for multiple international markets:
About the Author:
Michael Cassidy is a Wireless Compliance Consultant at Emergo.
(updated July 2015)