Cell Signaling Technology Announces ISO 13485 Certification
Certification enables increased support for partners and customers with industry-leading antibody reagents for commercial applications.
Danvers, MA, USA, July 16, 2026–Cell Signaling Technology (CST), a life science discovery technology company and leading provider of antibodies, kits, and services, today announced that its Beverly, MA, US and Leiden, NL facilities have achieved ISO 13485:2016 certification for its Quality Management Systems (QMS).
ISO 13485 is an internationally recognized quality standard. The ISO 13485 certification was received after a thorough audit of the QMS by the BSI Group, and reinforces CST’s commitment to the highest standards of quality and regulatory compliance in the manufacturing of antibody reagents.
“For more than 25 years, CST has had a reputation for scientific rigor, reagent quality, and product performance,” said Craig Thompson, Chief Operating Officer at CST. “Earning ISO 13485 certification is a natural next step that makes it easier for our partners in regulated markets to qualify CST as a supplier, knowing that our reagents meet stringent requirements for consistent product reliability.”
The ISO 13485 certification provides CST customers with the following advantages:
- QMS Alignment: Formally validates CST’s QMS against globally recognized benchmarks, enabling CST reagents to more easily be used in clinical research applications.
- Streamlined Qualification: Simplifies supplier qualification and regulatory compliance, reducing hurdles for customers seeking to use CST antibodies in commercial applications.
- Reduced Risk: ISO 13485 certification enables evolution from biomarker discovery by certifying that CST’s QMS can support the regulatory requirements for documented reproducibility, confirmed traceability, and supply continuity.
More than 95% of CST® products are produced in-house, eliminating supply chain disruptions. Additionally, over 97% of US and EU orders are delivered the next business day. This industry-leading reliability, backed by CST’s rigorous antibody validation standards and ISO 13485 certification, empowers customers with high-quality reagents for critical translational, diagnostic, and clinical applications.
Learn more about Cell Signaling Technology’s certifications.
About Cell Signaling Technology
Cell Signaling Technology (CST) is a different kind of life science company—one founded, owned, and run by active research scientists, with the highest standards of product and service quality, technological innovation, and scientific rigor. Founded in 1999 and headquartered in Danvers, Massachusetts, USA, CST employs over 600 people worldwide. We consistently provide fellow scientists around the globe with best-in-class products and services to fuel their quests for discovery. CST is a company of caring people driven by a devotion to facilitating good science—a company committed to doing the right thing for our customers, our communities, and our planet. cellsignal.com
