Spok Announces ISO 13485:2016 Certification
Comprehensive certification process further validates Spok as a trusted partner in the highly regulated healthcare industry.
ALEXANDRIA, Va., (February 7, 2023) – Spok, Inc., a wholly owned subsidiary of Spok Holdings, Inc. (NASDAQ: SPOK) and a leader in healthcare communications, announced today that it has received ISO 13485:2016 certification from DEKRA Certification Inc. (www.dekra.us) for the design and manufacture of Spok® Messenger, an intelligent, FDA 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. This achievement is a significant milestone for Spok and further confirms the safety and reliability of its class II medical device.
“We are proud to receive ISO 13485:2016 medical certification, which ensures that our solution maintains or exceeds key industry standards and guidelines,” said Vincent D. Kelly, chief executive officer of Spok Holdings, Inc.
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 that 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. They provide 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.