RegulatorySpine

Intertek Issues First UL 2900-2-1 Certification to Medical Device Manufacturer NuVasive, Inc.

The first UL 2900 certification issued by Intertek EWA-Canada signifies continued diversification of our core competencies and services

March 7, 2022

OTTAWA, Ontario–(BUSINESS WIRE)–Intertek, a Total Quality Assurance provider to industries worldwide, has issued its first UL 2900-2-1 certification to medical device manufacturer NuVasive, Inc. for Pulse, the company’s integrated technology platform that enables better spine surgeries. The certification was awarded by our Intertek EWA-Canada laboratory in Ottawa.

NuVasive Pulse Platform

UL 2900-2-1 is a standard for software cybersecurity that applies to the testing of network-connected components of medical devices, to assess the cybersecurity risk of the network and connectable components of healthcare and wellness systems. This inaugural certification by our operational staff in our Ottawa laboratory, combined with the participation of our cybersecurity analysts in Standards Technical Panels for all the UL 2900 family of standards, demonstrates Intertek’s competence in the entire range of UL 2900 standards through the delivery of complex and challenging assessments of connected medical devices. Our experience with cybersecurity for medical devices ranging from surgical robots to hospital monitoring equipment helps our clients eliminate security flaws, meet regulatory requirements, and launch successful products.

Tony Walker, Global Vice President, Connected World, said: “We are very pleased to have issued our first UL2900-1 certificate to NuVasive, helping ensure its innovative surgical system against the cybersecurity risks inherent in any connected product, and so helping bring the benefits of connectivity safely to patients to this important area of medicine. This also underscores our commitment to continued diversification of our core cybersecurity competencies and services across a number of industries.”

Intertek EWA-Canada has provided industry-leading cyber security services for more than 30 years. Initially serving defense, governmental and high-security clients, Intertek EWA-Canada has expanded into consumer and industrial IoT security testing for consumer, commercial, medical, and industrial products and systems.

ABOUT INTERTEK

TOTAL QUALITY. ASSURED.

Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely.

intertek.com

Contacts

FOR MEDIA INFORMATION:
Please contact
Amy Paille
PR & Content Manager, North America
+1 630 408 5538
amy.paille@intertek.com

FOR TECHNICAL INFORMATION:
Please contact
Steve Jia
+1 613 576 3514
steven.jia@intertek.com

Chris J. Stewart

Chris currently serves as President and CEO of Surgio Health. Chris has close to 20 years of healthcare management experience, with an infinity to improve healthcare delivery through the development and implementation of innovative solutions that result in improved efficiencies, reduction of unnecessary financial & clinical variation, and help achieve better patient outcomes. Previously, Chris was assistant vice president and business unit leader for HPG/HCA. He has presented at numerous healthcare forums on topics that include disruptive innovation, physician engagement, shifting reimbursement models, cost per clinical episode and the future of supply chain delivery.

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