Trajan Scientific and Medical has obtained the ISO 13485:2016 certification at both its Ringwood headquarters and Penang, Malaysia site. This certification marks a testament to Trajan's commitment to delivering high-quality products and services in the medical and scientific sectors. The certification not only underscores Trajan's commitment to quality but also enhances its capabilities to manufacture medical devices, meeting the stringent requirements of the industry.
"Attaining the ISO 13485 certification marks a significant milestone." said Rick Barber PhD, Chief Corporate Systems Officer at Trajan Scientific and Medical. "This achievement enables us to progress our manufacturing journey in medical devices. We are contributing towards healthcare outcomes and improving the quality of life for individuals worldwide, aligning with our collective vision of science that benefits people."
ISO 13485 is an internationally recognized standard that specifies requirements for a quality management system in the design, development, production, and distribution of medical devices. Achieving this certification demonstrates Trajan's adherence to stringent quality management practices, ensuring the consistency, safety, and effectiveness of our products.
For more information about our certifications, visit our quality and compliance page.
Trajan is a global developer and manufacturer of analytical and life sciences products and devices founded to enrich personal health through scientific tools and solutions. We aim to support science that benefits people. Trajan’s products and solutions are used in the analysis of biological, food, and environmental samples. Trajan has a portfolio and pipeline of new technologies which support the move towards decentralized, personalized data-based healthcare.
Trajan comprises more than 650 people with seven manufacturing sites across the US, Australia, Europe, and Malaysia, and operations in Australia, the US, Asia, and Europe. For more information, visit www.trajanscimed.com.