Business Wire

atsec AB first IEEE 2621 Accredited Medical Device Testing Facility

Share

atsec AB Stockholm, Sweden is thrilled to announce: We are the first IEEE Authorized Testing Facility!

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240403252100/en/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

IEEE certificate (Graphic: Business Wire)

We've officially been approved as an IEEE Authorized Testing Facility, making atsec AB Stockholm, Sweden the first company able to provide testing of medical devices according to the IEEE 2621 standard. Additional locations include atsec corporation Austin TX, USA and atsec GmbH Munich, Germany.

The IEEE, or Institute of Electrical and Electronics Engineers, is a globally recognized leader in developing technical standards. Earning their authorization as a testing facility demonstrates our capability to conduct rigorous and reliable security evaluations of medical devices according to the IEEE 2621 standard.

Importantly, the IEEE 2621 standard is recognized by the Food and Drug Administration (FDA), the leading regulatory body for medical devices in the United States. This recognition signifies that the FDA considers the standard to be a valuable tool in ensuring medical device security.

Proven Expertise Through Pilot Projects

"We enthusiastically embraced the opportunity to become a player in this domain when IEEE first contacted atsec in July 2022," said Sal La Pietra, President and founder of atsec.

"We're particularly proud of this achievement because it follows the successful completion of two pilot projects that used the IEEE 2621 standard for medical device testing. These projects allowed us to refine our processes and demonstrate our expertise in applying this standard," added Rasma Mozuraite Araby, Managing Director of atsec AB in Stockholm, Sweden.

Looking Ahead: Medical Device Testing

As an IEEE Authorized Testing Facility with laboratories in Sweden, the U.S., and Germany, atsec is now positioned to offer our clients a suite of testing services that ensure their medical devices meet the industry's security benchmarks. If you're looking for a reliable partner to verify the security of your medical devices, contact us today at info@atsec.com to discuss your specific needs.

Link to IEEE listing:

https://standards.ieee.org/products-programs/icap/programs/medical-devices-cybersecurity/#test-labs

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Andreas Fabis
Marketing Director
fabis@atsec.com
www.atsec.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Natus Sensory Appoints Arne Boye Nielsen to Board of Directors8.1.2026 09:00:00 EET | Press release

Natus Sensory, a global leader in sensory and diagnostic solutions, today announced the appointment of Arne Boye Nielsen to its Board of Directors, effective January 1, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260107392331/en/ Arne Boye Nielsen Arne brings more than 30 years of executive leadership experience in diagnostics and medical technology, most notably as President of Demant Diagnostics, where he built and scaled the business into a global leader over three decades. During his tenure, Arne played a central role in shaping Demant Diagnostics’ long-term strategy, portfolio expansion, and international growth, establishing it as a cornerstone of Demant’s global healthcare footprint. In addition to his executive leadership background, Arne brings extensive board experience. His deep expertise across diagnostics, governance, and value creation will further strengthen Natus Sensory’s Board as the company contin

4Moving Biotech Receives FDA IND Clearance for 4P004, Strengthening Its Position as a Leading Innovator in Disease-Modifying Osteoarthritis Therapeutics8.1.2026 08:30:00 EET | Press release

4Moving Biotech (4MB), a clinical stage biotechnology company developing next-generation, disease-modifying therapies for osteoarthritis (OA), today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for 4P004, enabling the expansion of the Phase 2a INFLAM MOTION clinical trial into the United States (US). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260107798042/en/ 4Moving Biotech (4MB), a clinical stage biotechnology company developing next-generation, disease-modifying therapies for osteoarthritis (OA), today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for 4P004, enabling the expansion of the Phase 2a INFLAM MOTION clinical trial into the United States (US). The U.S. Food and Drug Administration (FDA) approval marks another strategic step in 4MB’s global clinical deployment across

Organon Enters into a Commercialization Agreement for Daiichi Sankyo’s Nilemdo ® in France, Denmark, Iceland, Sweden, Finland and Norway8.1.2026 08:30:00 EET | Press release

Organon today announced that it has entered into an agreement with Daiichi Sankyo Europe to commercialize Nilemdo® (bempedoic acid) in France, Denmark, Iceland, Sweden, Finland and Norway. Nilemdo® is a new, first-in-class drug indicated for patients with high cholesterol and cardiovascular disease risk. It provides an alternative treatment for patients that cannot be treated effectively with statins.ii “This collaboration combines Organon’s commercial agility with Daiichi Sankyo’s expertise in cardiovascular innovation to bring Nilemdo® to patients in France, Denmark, Iceland, Sweden, Finland and Norway,” says Thibault Crosnier Leconte, AVP & Managing Director at Organon Northwest Europe. “By offering a new treatment option for patients who cannot tolerate statins, we are helping to close a persistent gap in cardiovascular care—one that disproportionately affects women – whilst reinforcing our mission to deliver impactful treatments for a healthier every day.” Cardiovascular disease i

Azafaros to Present at J.P. Morgan’s 44 th Annual Healthcare Conference8.1.2026 08:00:00 EET | Press release

Azafaros, a company building a portfolio to become a leader in lysosomal storage disorders with the goal of addressing neurological symptoms, today announced that it will present at J.P. Morgan’s 44th Annual Healthcare Conference on Thursday, January 15. The company’s presentation will begin at 9:30 am PT/12:30 am ET/6:30 am CET. The presentation will focus on the company’s lead product, nizubaglustat, a potential treatment for rare lysosomal storage disorders with neurological involvement including GM1/GM2 gangliosidoses and Niemann-Pick type C disease ((NPC). Two pivotal Phase 3 studies investigating nizubaglustat in GM1/GM2 gangliosidoses and NPC are currently enrolling, with data expected in 2027. The studies build on positive data from a robust clinical program including the Phase 2 RAINBOW study and the PRONTO natural history study. The Phase 3 studies are financed following the company’s successful completion of €132 million series B round completed in 1H 2025. About nizubaglust

Prodapt Earns ISO 42001 Certification, the New Global Benchmark for Responsible Enterprise AI8.1.2026 08:00:00 EET | Press release

Prodapt today announced that it has been awarded the ISO 42001 certification, the world’s first and the only global standard for AI Management Systems (AIMS). Marking a significant milestone in its journey, Prodapt is setting a higher benchmark to deliver secure, ethical, and scalable AI for global enterprises. ISO 42001 lays a rigorous framework for governing AI across strategy, technology, and operations. The certification, awarded by an independent accredited body, validates Prodapt’s enterprise-grade AI management framework, including executive-led oversight, strong technology foundations, and disciplined operational processes. These measures ensure AI systems are responsibly designed, deployed, monitored, and evolved throughout their lifecycle. The evaluation emphasizes risk management, ethical AI practices, transparency, and scalability, confirming Prodapt’s ability to proactively identify and mitigate risks while ensuring accountability in AI-driven outcomes. Human-in-the-loop c

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye