Quality and Regulatory Services

//Quality and Regulatory Services
Quality and Regulatory Services 2017-07-10T15:58:19+00:00

At LSO we are committed to providing clients with the highest quality products. To this end we take meticulous care in maintaining our industry certifications, registrations and licenses, by adhering strictly to guidelines as per the prescribed quality systems. Furthermore, LSO also implements productivity and quality enhancing methodologies such as Just-in-time (JIT) manufacturing, effective measurement systems and incentivized quality control to achieve continuous improvement.

International Organization Standards & Certifications: ISO & FDA

LSO is ISO 13485:2003 certified, which is defined as – “ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.” In addition, as the sole Contract Steam Sterilization provider on the west coast, we also possess ISO 17665:2006 certification.

LSO is also registered as a medical device contract manufacturer and a contract sterilizer by the United States Food and Drug Administration (FDA). Maintaining this status requires following the FDA Quality System Regulations and undergoing regular audits. We are also certified as medical device manufacturers of sterile and no-sterile devices by the ‘Japan Minister of Health’. Finally LSO and its divisions also follow various standards set by institutions such as cGMP/QSR, ISO, ISTA and ASTM, to perform manufacturing, sterilization and package testing activities.

We are here to help

If you’re ready to begin your project or if you need more information; send us an email or give us a call at (714) 672-1090. We have a highly knowledgeable team ready to assist you and answer all of your questions.

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