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What certifications does LSO currently hold?
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FDA CDRH Registration: Contract Manufacturer, Contract Sterilizer |
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View Certificate |
State of California: Device Manufacturing License |
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State of California: Drug Manufacturing License |
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State of California: Board of Pharmacy License |
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View Certificate |
International Standard ISO 13485:2003 |
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International Standard ISO 17665:2006 Moist Heat Sterilization |
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ISTA Certified Package Testing Laboratory |
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Japan Minister of Health: Medical Device Manufacturer, Non Sterile Devices. |
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Japan Minister of Health: Medical Device Manufacturer, Sterile Devices. |
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View Certificate |
Does LSO provide any pre and post-production services?
Through our six divisions, LSO is capable in supporting activities from development through production. Service divisions include:
- Medical Device Manufacturing
- Medical Package Testing
- Sterilization Validation Services
- Fulfillment & Distribution Services
- Offshore Manufacturing
- LSO Incubator Services
Additionally we also provide Engineering Services (MDM) and Cleaning & Disinfection Services (SVS).
Where are you located?
LSO is located in Brea, California, about 30 minutes from the nearest Medical Device hub in Irvine. We are also in close proximity to LAX Airport and Long Beach Port. Our location allows for greater monitoring and on-hands involvement with our Offshore Manufacturing partner, conveniently located just south of the border in Tijuana, Mexico. Our customers include both domestic and international clientele.
What is the size of LSO's facility?
LSO is a 56,000 square foot facility consisting of 10,000 sq. ft. of Class 10,000, 500 sq ft of Class 1000 and 180 sq ft of Class 100 clean rooms, 8,000 sq. ft. of office space and the remainder dedicated to storage and warehousing.
What does LSO offer with its Facility Utilization Option?
LSO can assist early stage companies that may not be registered with the FDA as a manufacturer or any Medical Device company without their own facilities, the opportunity to use LSO Class 10,000 clean rooms. We provide an option to rent clean room space on a daily basis to build prototypes or small lots and use equipment and engineering staff to assist you in the early stages of product development.
How can I stay updated on LSO services, events and news?
In addition to the company website, LSO and industry news is regularly updated on to our Facebook page and Twitter account. You can also follow us on the Company Blog where we delve deeper into industry events and trends. Finally you can find us on YouTube through our corporate channel. In the near future we also hope to bring to you an industry newsletter.
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What markets does LSO primarily serve?
LSO has been in business for fourteen years and has served approximately 250 companies. There are several clinical spaces and market segments that we have served. Please see the list below:
- Orthopedic
- Cardiac Rhythm Systems
- Cardiovascular
- Neurovascular
- Respiratory
- Gastrointestinal
- Dental Implants
- Minimally Invasive Devices
- Specialty Kits
- Oncology
Who is LSO's typical customer?
LSO works with a variety of different size and types of medical device companies. We are most appealing to companies looking for the following advantages:
- Turnkey Solutions
- Cost & Efficiency Savings
- Reduced Overhead
- Ability and Flexibility to Focus on your Core Activities
- Quicker Time to Market
- Access to Industry Expertise
- Staffing Flexibility
- Risk-Sharing / Management
What measures do you take to protect the customer's intellectual property?
LSO operates under a Non-Disclosure Agreement with all companies, prior to beginning discussions. In addition, when these companies become customers, they are assigned a three letter code, to protect their privacy. All internal discussions, documentation and warehousing facilities reflect only the companies' letter code, to insure privacy and confidentiality.
What is the Inquiry Response Time?
The inquirer immediately receives a return email acknowledging receipt of their inquiry. In most cases, the individual is contacted with an hour or two for initial discussions and questioning.
How long does it take for a quote?
LSO is extremely sensitive to the customer's needs and will develop a quote as rapidly as necessary to fulfill necessary timelines.
What are the next steps if I want to discuss my project with LSO?
Once an NDA is in place, a phone conference is generally scheduled to begin discussions.


