Unlike other medical device incubators, QIS does not require an equity position in the incubator company, which is a unique approach. Once engaged, LSO will entertain future equity positioning in return for services. Client companies can confidently outsource all or portions of the engineering, supply chain management, clinical builds, warehousing, product manufacturing, sterilization, testing, validations and final distribution of devices to LSO. Our 56,000 sq. ft., fully functional facility located in Brea, CA houses our incubator offices, clean rooms (class 100, 1000, 10000), warehouse, administrative offices and all divisional support of LSO. Our clients appreciate the cost and resource savings, flexibility and superior quality advantages gained by having all services in one central location.
Our team at QIS works closely with our clients as true partners in their growth, creating value over the long term. Our mission is to provide entrepreneurs with the resources and experience they need to commercialize their technology within the shortest amount of time.
QIS is an integrated, turnkey manufacturing facility equipped with office space, clean rooms and experienced manufacturing professionals, providing numerous services to start up medical device companies. QIS clients, in addition to gaining access to services and capabilities provided by Life Science Outsourcing, Inc., can also benefit from special programs tailored to meet the individual needs of each incubator company.
Now imagine, either your virtual or physical office, located in an FDA registered, ISO 13485 certified facility with complete access to a well-designed quality system. You can invite your investors, potential clients and suppliers to meet with you at your office and cleanroom to discuss business and demonstrate the development of first article, as well as, clinical or commercial product being built in your certified facility.
You will also have seasoned professionals sitting with you, assisting with FDA/ ISO audits to obtain 510K or CE Marking. You will have the freedom to focus on other aspects of your business, while we do the rest. From the moment that you become an QIS client, you can operate under our quality umbrella while QIS is creating your abbreviated Quality System. You will have complete access to your DHR and DMR at all times. QIS can order, receive and inspect your parts from qualified vendors, ready to be used by you or our trained technicians dedicated to your project.