Our quality management system certification to the ISO13485 standard by British Standards Institute (BSI, Inc) assures our customers that Lucigen has a compliant and effective system in place to deliver the highest quality products that you expect. This standard describes the requirements for developing, producing, distributing, and maintaining high quality products and services for scientists working in the medical and life sciences. Lucigen’s quality system is registered to the ISO13485 international standard for the design, manufacture, and distribution of medical devices. Lucigen’s work is organized to understand what customers require, to design the most reliable way to produce and deliver it, and to measure how we are doing every step of the way.

Process-based quality starts with the principle that the customer is the final judge of any company’s value. Lucigen has adopted a process-based quality management system as the way we accomplish our daily work and deliver the products you require when you need them. If you are interested in OEM opportunities with Lucigen, please visit our MDx OEM page. You may re-use this information (not including logos) free of charge in any. Lucigen provides OEM solutions to companies that need ISO 13485 certified manufactured reagents. We will only earn your loyalty and trust by consistently delivering defect-free products, reliable technical information, and effective help in using our products to achieve your research goals.

Lucigen strives to provide our customers with the highest quality products, services, and technical support for DNA and RNA cloning, next generation sequencing, amplification, detection, and protein expression. IMSXpress ISO 13485 Template Documentation is part of IMSXpress ISO 13485 software.

Iso 13485 pdf free