HSE•AG, a leading provider of laboratory automation, is proud to announce that it is now certified according to the ISO 13485:2016 standard (December 2017).
Why ISO 13485?
ISO 13485 is a standard that defines the requirements for the implementation and maintenance of an independently audited quality management system. It is strongly aligned with the FDA’s Quality System Regulation 21 CFR Part 820 (cGMP) and is considered to be best practice for quality management systems in the medical device industry.
The ISO 13485:2016 international standard requires consistent fulfillment of customer and applicable regulatory requirements relating to the safety and performance of medical devices.
By gaining this important and internationally recognized certification, we have achieved a very important milestone in the history of our young company. It provides a foundation for expanding our business activities and providing customers with high-quality services in the medical device and in vitro diagnostic markets.
Hombrechtikon Systems Engineering AG (HSE•AG) has been at the leading edge of lab automation for 20 years. With this proven track record, we are committed to developing automated systems that enable science and technology to evolve and accelerate your next breakthrough. A prerequisite for this is application-centric development of integrated systems.
HSE•AG customizes innovations to specific customer needs and provide support at the interface of systems engineering and in vitro applications. HSE•AG’s track record in applications and technologies such as next-generation sequencing, PCR, capillary electrophoresis, liquid handling, and sample preparation enables the company to successfully handle the complexities of workflow automation.
Do you want to see the HSE•AG ISO 13485:2016 certificate? Download this certificate by clicking on the button below:
Posted by Patrick Widler