New Partnership between Hamilton and Platomics
High tech lab automation paired with high tech regulatory automation: Hamilton and Platomics announce partnership to provide EU clinical labs with a digital solution for documenting their in-house diagnostic tests in compliance with the new EU regulations
Bonaduz and Vienna, - July 2024 - Laboratory automation manufacturer Hamilton and regulatory automation provider Platomics have joined forces to enable clinical laboratories manufacturing in-house in-vitro diagnostic devices (IH-IVDs) with integrated Hamilton products to comply with the requirements of the EU In Vitro Diagnostic Regulation (IVDR).
Hamilton has registered its liquid handling platforms based on STAR and STAR V on Platomics’ regulatory platform PlatoX®, with more products to follow. This will enable clinical laboratories across the EU to access required technical documentation on Hamilton products in the PlatoX® product database and integrate it into their digital documentation for in-house tests.
PlatoX® automates the extensive technical documentation now required for in-house tests, greatly streamlining and expediting the compliance path. The platform connects labs and manufacturers to automate the exchange of data and simplify regulatory processes between stakeholders.
"The digital documentation of the PlatoX® Lab Assistant allows our customers to record their internal laboratory workflows in their quality management system within a very short time and meet IVDR requirements with professional guidance. Our team supports Platomics in providing the essential product documentation so that it can be captured in the PlatoX® product database and easily integrated into the documentation. In the digital age, it is important to Hamilton to provide its customers with up-to-date support for its products, not only in terms of application and technical support, but also with regard to quality management and regulatory requirements" says Dr. Frank Streckenbach, Market Segment Leader Diagnostics at Hamilton Bonaduz AG.
"Hamilton provides state-of-the-art automation for liquid handling in clinical laboratory testing and has partnered with Platomics to provide their customers with equally state-of-the-art automation for the complex regulatory work required under the IVDR. Platomics’ services allow laboratories to quickly reach compliance for their in-house tests, whether with technical documentation in the Lab Assistant or with our NGS Validation Service,” DI Dr. Albert Kriegner, CEO at Platomics.
Platomics automates regulatory processes and connects in vitro diagnostic manufacturers, laboratories, and regulators to accelerate compliance and bring innovation to patients faster. The PlatoX® platform saves time, resources and costs for all stakeholders involved in IVDR compliance by digitalizing regulatory work on the basis of intelligent data, not docs.
Hamilton is a leading global manufacturer, providing automated liquid handling workstations and laboratory automation technology to the scientific community. With a focus on innovative design, Hamilton products incorporate patented liquid handling technologies into a portfolio that includes liquid handling platforms, standard application-based solutions, small devices, consumables, and OEM liquid handling solutions. Known for advancing life science, clinical diagnostics, forensics, and biotechnology industries, Hamilton products offer reliability, performance, and flexibility. Ensuring a continuous commitment to quality, Hamilton utilizes state-of-the-art manufacturing at production facilities in Reno, Nevada, and Bonaduz, Switzerland and has earned a global ISO 9001 certification. Privately held, Hamilton maintains headquarters in Reno, Nevada; Franklin, Massachusetts; and Bonaduz, Switzerland, along with subsidiary offices throughout the world.
www.hamiltoncompany.com/robotics
Media Contact:
Dr. Jörg Katzenberger
Hamilton Robotics
+49 89 248 804 119
Jkatzenberger@hamilton.ch