Michael Barbella, Managing Editor04.04.23
Spok Inc. has received ISO 13485:2016 certification from DEKRA Certification Inc. for the design and manufacture of Spok Messenger.
The company touts Spok Messenger as an intelligent, U.S. Food and Drug Administration 510(k)-cleared solution that sends critical information and updates from hospital alert systems such as nurse call, patient monitoring, and many others to mobile staff on their communication devices. The certification is a significant milestone for Spok and further confirms the safety and reliability of its class II medical device, according to Spok bigwigs.
“We are proud to receive ISO 13485:2016 medical certification, which ensures that our solution maintains or exceeds key industry standards and guidelines,” Spok Holdings CEO Vincent D. Kelly said.
ISO 13485:2016 is an internationally recognized quality standard specific to the medical device industry that ensures the quality of medical device design, development, and production. To receive certification, organizations must demonstrate their Quality Management Systems deliver medical devices and related services that consistently meet customer and regulatory requirements.
Spok Messenger is an integral part of the Spok Care Connect unified communication platform, which provides care team collaboration, closed loop communication, and secure messaging to enhance clinical workflows. Spok connects people and technology to drive communication efficiency, speed response times, and keep safety and satisfaction at the forefront.
With a deep understanding of worldwide regulations and requirements, DEKRA is a preferred partner of the healthcare and medical industries. It provides a range of certification, audit, and testing solutions focused on ensuring compliance with global standards, facilitating global market access, and increasing profitability. DEKRA’s solutions are tailored to meet the specialized demands of manufacturers of medical devices and component parts.
Spok Inc., a wholly owned subsidiary of Spok Holdings Inc., is headquartered in Alexandria, Va. Hospitals rely on the Spok Care Connect platform to enhance workflows for clinicians and support administrative compliance. Spok customers send more than 100 million messages each month through their Spok solutions. Spok is a trademark of Spok Holdings Inc. Spok Mobile and Spok Care Connect are trademarks of Spok Inc.
The company touts Spok Messenger as an intelligent, U.S. Food and Drug Administration 510(k)-cleared solution that sends critical information and updates from hospital alert systems such as nurse call, patient monitoring, and many others to mobile staff on their communication devices. The certification is a significant milestone for Spok and further confirms the safety and reliability of its class II medical device, according to Spok bigwigs.
“We are proud to receive ISO 13485:2016 medical certification, which ensures that our solution maintains or exceeds key industry standards and guidelines,” Spok Holdings CEO Vincent D. Kelly said.
ISO 13485:2016 is an internationally recognized quality standard specific to the medical device industry that ensures the quality of medical device design, development, and production. To receive certification, organizations must demonstrate their Quality Management Systems deliver medical devices and related services that consistently meet customer and regulatory requirements.
Spok Messenger is an integral part of the Spok Care Connect unified communication platform, which provides care team collaboration, closed loop communication, and secure messaging to enhance clinical workflows. Spok connects people and technology to drive communication efficiency, speed response times, and keep safety and satisfaction at the forefront.
With a deep understanding of worldwide regulations and requirements, DEKRA is a preferred partner of the healthcare and medical industries. It provides a range of certification, audit, and testing solutions focused on ensuring compliance with global standards, facilitating global market access, and increasing profitability. DEKRA’s solutions are tailored to meet the specialized demands of manufacturers of medical devices and component parts.
Spok Inc., a wholly owned subsidiary of Spok Holdings Inc., is headquartered in Alexandria, Va. Hospitals rely on the Spok Care Connect platform to enhance workflows for clinicians and support administrative compliance. Spok customers send more than 100 million messages each month through their Spok solutions. Spok is a trademark of Spok Holdings Inc. Spok Mobile and Spok Care Connect are trademarks of Spok Inc.