TÜV Rheinland Adds Wireless Coexistence Testing Capability to Support Medical Device Compliance

The new capability allows device manufacturers to comply with AAMI TIR 69 and ANSI C63.27, a required compliance submission to the FDA.

Cologne, GERMANY

LITTLETON, Mass., Aug. 04, 2020 (GLOBE NEWSWIRE) -- TÜV Rheinland of North America, a global leader in independent technical services, today had announced a new wireless device testing capability in accordance with the C63.27-2017 American National Standard for Evaluation of Wireless Coexistence. One of the most highly regarded tests, Wireless Coexistence testing supports medical device manufacturers in complying with FDA-mandated requirements by providing pertinent information for regulatory submissions. TÜV’s testing capability will be available at the Product Safety & EMC Excellence Center, located in Pleasanton, CA - TÜV’s largest U.S. testing lab.

With the majority of people spending most of their time online during the pandemic, the country’s reliance on wireless connectivity has become critical to staying engaged - especially for healthcare professionals. For healthcare facilities using digital tools and wireless devices, the ability to safely share information with minimal product errors is essential to fighting the battle against Covid-19. Medical device manufacturers need to prepare for the variety of risks that can arise from connections coexisting in an environment where wireless is being heavily employed, both for healthcare and non-healthcare uses e.g. mobile and household appliances or smart homes.

TÜV’s expanded wireless testing capabilities will support a more efficient and convenient testing process for medical device manufacturers looking to comply with multiple standards from a single provider. This approach aligns with TÜV’s Under One Roof” effort to drive higher levels of operational efficiencies, by offering holistic testing in one place. The “Under one Roof” effort began in 2017 with the opening of the Wireless & IoT Excellence Center in Fremont, CA and has expanded over the last three years. The program’s goal is simple: Become the best service delivery company in the industry.

“The TÜV team is here to provide the knowledge, expertise and capabilities necessary for customers to streamline their product safety procedures - all under one roof. By obtaining all product testing and certifications from a single source, manufacturers can increase efficiency within their product delivery and compliance process with U.S. safety regulations.” Said Sarbjit Shelopal, the Director Electrical & Wireless Test Services at TÜV Rheinland of North America.

For more information on TÜV Rheinland’s Global IoT / Wireless Testing and Certification services, visit https://www.tuv.com/landingpage/en/wireless/.

About TÜV Rheinland:

TÜV Rheinland is a global leader in independent inspection services, founded nearly 150 years ago. The group maintains a worldwide presence of more than 20,000 people. The independent experts stand for quality and safety for people, technology and the environment in nearly all aspects of life. TÜV Rheinland inspects technical equipment, products and services, oversees projects, and helps to shape processes and information security for companies. Its experts train people in a wide range of careers and industries. To this end, TÜV Rheinland employs a global network of approved labs, testing and education centers. Since 2006, TÜV Rheinland has been a member of the United Nations Global Compact to promote sustainability and combat corruption. Website: www.tuv.com

TÜV Contact Information:

Jen Picardo
Director of Communications
TÜV Rheinland of North America, Inc.