Business Wire

atsec AB first IEEE 2621 Accredited Medical Device Testing Facility

3.4.2024 19:34:00 EEST | Business Wire | Press release

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

Galderma Provides Progress Update Regarding RelabotulinumtoxinA Regulatory Submission in the United States1.7.2026 08:00:00 EEST | Press release

Galderma (SIX: GALD) today provided progress updates regarding the regulatory review of its pending Biologics License Application (“BLA”) for RelabotulinumtoxinA with the U.S. Food and Drug Administration (“FDA”). The Company has received a Complete Response Letter (CRL) from the FDA with comments related to observations during manufacturing site inspection and analytical method optimization. As part of its review, the FDA conducted a Pre-License Inspection (PLI) of Galderma’s manufacturing site. All other aspects of the BLA, including safety- and efficacy-related parts, did not solicit deficiencies to be addressed. The FDA made observations during the PLI for which Galderma is putting in place corrective and preventive actions. Galderma will also be seeking further guidance through continued open dialogue with the FDA toward resolution of the relevant observations. Galderma plans to rapidly respond to the CRL and advancing RelabotulinumtoxinA in the U.S. remains a top priority. The ob

EVE Energy Showcases All-Scenario Energy Storage Solutions at The Smarter E Europe 20261.7.2026 04:45:00 EEST | Press release

EVE Energy unveiled its Mr. Big Family series, a 6.9+ MWh energy storage system, and all-scenario energy storage solutions at Intersolar Europe in Munich. Drawing on traceable large-cell technology, proven large-scale energy storage project delivery experience, and global delivery capabilities, the company is addressing Europe's diverse energy storage requirements across utility-scale, commercial & industrial (C&I ), and data center segments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260630889717/en/ EVE Energy showcases its Mr. Giant 3.0 6.9+ MWh energy storage system at The Smarter E Europe 2026 in Munich, Germany Advancing Large-Cell Technology with Global Project Validation As one of the first companies to focus on large-capacity energy storage cells, EVE Energy has iteratively upgraded its cell platform from 560 Ah and 628 Ah to 702 Ah, adhering to a stacking process route throughout. At the exhibition, the Mr. Gia

Bending Spoons S.p.A. announces pricing of initial public offering1.7.2026 02:56:00 EEST | Press release

Bending Spoons S.p.A. (“Bending Spoons”), a leading technology company, today announces the pricing of its initial public offering (“IPO”) at $29.00 per share. A total of 57,971,015 ordinary shares are being offered, of which 34,398,640 shares are being offered by Bending Spoons and 23,572,375 shares are being offered by certain selling shareholders (the “Selling Shareholders”). Bending Spoons will not receive any proceeds from any sale of shares by the Selling Shareholders. The shares are expected to begin trading on the Nasdaq Global Select Market under the ticker symbol “BSP” on July 1, 2026. The offering is expected to close on July 2, 2026, subject to customary closing conditions. In addition, Bending Spoons and the Selling Shareholders granted the underwriters an option to purchase up to an additional 5,244,026 ordinary shares from Bending Spoons and up to an additional 3,451,626 ordinary shares from the Selling Shareholders at the initial public offering price, less underwriting

FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products30.6.2026 19:19:00 EEST | Press release

Philip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized ZYN products: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” “FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America,” saidStacey Kennedy, PMI U.S. CEO. “Today’s news ensures these adultshave access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease and lung cancer,” she added. “More broadly, it reinforces the agency’s science-based approach to evaluating products across the co

Caidya Announces Strategic Combination with Simbec-Orion Bridging Early Scientific Insight and Global Clinical Execution30.6.2026 18:00:00 EEST | Press release

Caidya today announced a strategic combination with Simbec-Orion designed to close the divide between early scientific insight and global clinical execution. The combination of Caidya and Simbec-Orion creates a differentiated specialty clinical CRO platform that enables programs to scale, maintaining focus, speed, and accountability. The strategic combination brings together complementary strengths to create a more complete development partner for innovative biopharma companies. With established operations across Europe, the Americas, APAC, and China, the combined organization provides meaningful expertise and execution capabilities in the regions that matter most. Simbec-Orion brings early-phase clinical pharmacology capabilities alongside deep therapeutic expertise for later stage complex oncology and rare disease trials, helping sponsors shape critical decisions early in the development lifecycle. Together, the organizations strengthen their ability to support complex, cross-border

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