As our clients expand their business, so too does our manufacturing capacity. Large scale production of devices is handled by our sister facility through our Offshore Manufacturing partner, conveniently located just south of the border in Tijuana, Mexico. The facility employs 180 highly skilled staff, is FDA registered and ISO 90001:2000 certified.
Over the past few years offshoring of medical device manufacturing has been growing in popularity, with offshore countries becoming increasingly committed to higher quality levels and regulatory standards.
As an early beneficiary of offshoring, LSO had the opportunity to choose amongst Mexico's many qualified partners/facilities. Our partner's in Mexico have a proven track record and are reputed as a premier manufacturer for the Medical Device industry.
The Offshore facility has a 22,000 square foot production area with over 2000 square feet dedicated to clean rooms. The Clean Room is ISO 14644 class 7 and certified by the CERTS (Controlled Environment Regulatory Testing Services) of CA, USA. A strong emphasis is placed on complete traceability and transparency of device history records for every lot of product that we manufacture for you. Our Offshore Manufacturing Partner will also handle all labor, legal, and administrative tasks, while you maintain control of production quality.
Whether you are a medical device start-up or a well established incumbent, LSO has the production capability and the experienced staff to provide you with a turnkey solution to all your manufacturing needs and more.