Startups creating new medical devices and growing commercial OEMs requiring surge capacity can rent our Class 7 (Class 5 pharma) cleanroom space and equipment to build prototypes, small lots, or scale production, all while benefitting from LSO engineering staff support.
Life Science Outsourcing offers Class 7 cleanroom rentals for startups and growing commercial OEMs requiring surge capacity. With a regulatory-ready environment and engineering support, our facilities provide the flexibility needed for prototyping, small-scale production, or scaling operations—allowing you to focus on delivering high-quality medical devices.
A cleanroom provides the necessary environment to bring new medical device innovations to life. The controlled environment, strict protocols, and continuous monitoring ensure that your new devices are compliant and safe for the end user.
Contamination control
Medical devices must meet strict sterility and cleanliness standards. Cleanrooms provide a controlled environment with low levels of pollutants (dust, airborne microbes, and aerosol particles) to prevent contamination during manufacturing.
Product integrity
Medical device integrity and functionality can be compromised by contamination, no matter how minimal. Cleanrooms help your products achieve the highest quality for patient safety and overall effectiveness.
Regulatory standards
The U.S. FDA and other regulatory bodies require that medical devices are manufactured in environments that control contamination risks. A cleanroom is often necessary to meet such regulatory requirements.
A cleanroom meets several important criteria to ensure patient safety, achieve regulatory approval, and make your products more competitive in the market.
Startups generally do not have space or cleanrooms to perform medical device sample production. That’s where Life Science Outsourcing can help. We’re committed to helping medical device manufacturers find the answers and solutions they need to bring their innovations to life quickly and efficiently.
LSO can provide Class 10,000/ISO 7-rated cleanroom space to early-stage companies that may not be registered with the FDA or that do not have their own facilities. We provide an option to rent cleanroom 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.
With state-of-the-art facilities in California, New Hampshire and Costa Rica, Life Science Outsourcing supports over 125,000 total square feet of dedicated medical device manufacturing, assembly, packaging and sterilization space.
These sites include 12 total Class 5, 6, 7 and 8 cleanrooms, including a Class 7 dry room. Within these rooms are spaces dedicated to low-humidity manufacturing and solvent scouring for careful handling of bioabsorbable polymers.
Each site also features over 30,000 square feet of warehouse space with multiple shipping and receiving bays for flexible raw material and finished product staging.
Our medical device incubator services offer comprehensive support for medical device development, including facility utilization, quality management guidance, FDA registration assistance, clinical and R&D builds, full traceability, and product packaging and validation support
Comprehensive packages for regulatory compliance.
From fractional to full cycles with EtO residual testing.
Secure with 2X qualification.
Tailored to your sterilization needs.
Life Science Outsourcing is an FDA registered and ISO 13485 certified full service Medical Device Contract Manufacturer.
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