Life Science Outsourcing offers turnkey medical device manufacturing and assembly services that can be combined with our engineering and process development solutions to create a streamlined and comprehensive process.
Life Science Outsourcing’s deep expertise makes us the industry’s leading “one-stop shop” for medical device needs with noted expertise in four major manufacturing techniques – Precision Assembly & Testing, Catheter Assembly, Electromechanical Assembly, and Combination Product Assembly.
Life Science Outsourcing provides comprehensive precision assembly and testing services for medical device manufacturers.
Life Science Outsourcing specializes in the assembly of single-use catheters. We have assembled a variety of catheters for a diverse range of functions, from basic Foley and angiography to radiofrequency and balloon cardiology catheters.
All Catheter Assembly is performed at one of our many Cleanroom spaces (Class 100, 1000 and 10000). Our team can produce catheters of varying materials and design.
To provide clients with single sourcing of finished catheters, Life Science Outsourcing offers:
Life Science Outsourcing provides comprehensive electromechanical assembly and testing. Our capabilities include dedicated assembly facilities, in-process, and final testing capabilities. We have a dedicated and trained staff with a proven track record for ensuring high-quality products at a competitive price, with an extensive network of highly rated vendors.
Electromechanical Assembly services include:
Electromechanical Assembly Process Capabilities:
Electromechanical Assembly Engineering Support:
The Food & Drug Administration defines a Combination Product as: “Therapeutic and diagnostic products composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.”
Some estimates suggest that up to 30% of recent FDA submissions are combination products. As a result of this growing trend, the FDA has set up a separate department for the review of such products.
The potential benefits of Combination Products include:
At Life Science Outsourcing, all Combination and BioPharm product activities such as Fill / Package are performed in a Class 100 Cleanroom. All manufacturing and warehousing is cGMP compliant. Our featured services include the low-cost and rapid scale-up manufacturing of Phase I Pharmaceuticals and Combination devices.
Combination Product Specialties:
Life Science Outsourcing offers startup companies a unique service – access to space, equipment, and a skilled staff in our FDA registered / ISO 13485 certified facility.
LSO allows startups to build prototypes and small lots in Class 10,000 (ISO 7) and Class 100 (ISO 5) clean room space, with numerous benefits:
Life Science Outsourcing offers a comprehensive set of process development services: