Medical device innovators today require a gamut of services to successfully take their products to market within tight timelines. Gone are the days when piecemealing regulated services were enough to get the job done – today’s modern market demands that device companies do more, faster, and with fewer resources. One solution is to align with a reliable outsourcing partner who can handle a multitude of regulated medical device turnkey solutions. Manufacturing, package testing, and sterilization are all critical aspects, as are proper documentation and meeting regulatory expectations.
To be successful, medical device companies must streamline efficiencies, reduce costs, and free up time to focus on what matters: innovation. That’s where Life Science Outsourcing comes in. Device companies, large and small, rely on our one-stop-shop contract manufacturing and related services, which help them to start up, speed up and scale up in a dependable manner that can meet the rigors and challenges of their specific projects.
Innovators can accelerate time to market with Life Science Outsourcing’s five robust service divisions designed to support complicated medical device projects, including the opportunity for expedited services to meet strict project timeline criteria.
Medical Device Assembly
Bring your innovations to life with our state-of-the-art manufacturing equipment and assembly expertise. Your goal is to get your device commercially ready as soon as possible – and ours is to make that a reality. Our solutions extend to medical and pharmaceutical start-ups and original equipment manufacturers, including orthopedic, biopharmaceutical, and in vitro diagnostics. We’ll help you plan, construct, and commercialize your products quickly and reliably while navigating complex regulatory environments for you.
Achieve your ideal device outcome with our specialized manufacturing specialties, including catheter assembly, electromechanical assembly, and combination products, and engineering specialties, such as process development, tooling, and documentation.
Medical Package Testing
Package testing with the right partner offers a seamless process that delivers on its promise of superior packaging validation, testing, and design with minimized costs and satisfying regulatory requirements. Life Science Outsourcing can help you with all of the above, including package design, package validation testing, distribution simulation testing, and stability testing.
Adhering to industry standards is a priority for us, and we comply with the American National Standards Institute (ANSI), Association for the Advancement of Medical Instrumentation (AAMI), American Society for Testing & Materials (ASTM), International Organization for Standardization (ISO) and International Safe Transit Association (ISTA) standards.
Sterilization and Validation
With Life Science Outsourcing, you have access to an experienced sterilization and validation team with knowledge and capabilities that can select the ideal sterilization methodology for your device and is backed by our expansive quality assurance system.
Access the sterilization services you need, from heat and high pressure to chemical and radiation sterilization processes that maintain proper methods to deliver safe and compliant products. You can have confidence in the proper sterility level for your devices with our medical device testing, which includes biological indicator testing and chemical indicator testing, and our validation services which ensure that protocols and documentation outline an effective and compliant process.
Cleaning and Decontamination
Find the comprehensive, hard-to-find services right here with Life Science Outsourcing. We’ll streamline the decontamination process and reduce your costs with cleaning, decontamination, sterilization, loaner kit processing, quality inspection, sterility assurance level services, and packaging/transport guidelines.
We are one of the few regulated decontamination service providers on the west coast that offers ethylene oxide (EtO), an effective sterilization process that does not damage the device, and irradiation (gamma or e-beam), steam sterilization and dry heat sterilization.
Fulfillment and Distribution
The last thing medical device manufacturers need to worry about is supply chain management. They find Life Science Outsourcing fulfillment and distribution services to be a big benefit to their medical device process for timely and cost-effective logistics, from warehousing and inventory to packaging and delivery.
We can reduce your labor costs, increase your efficiency, and give you the ability to focus on what matters: your core business. Rely on our supply chain management, order processing, procurement, warehousing, packaging, and kitting, quality assurance, and shipping and distribution services to streamline your operations.
Quality Incubator Support
Entrepreneurs need to commercialize their technology in the shortest possible time – and we’re here to make it happen. Startups and established device companies can use our quality incubator support to develop a product and get it to market faster.
We offer a virtual location, quality management system guidance, FDA registration guidance, and registration and implementation of unique device identification system requirements. Combine this support with the full spectrum of regulated services Life Science Outsourcing offers for a truly comprehensive experience designed to deliver your product faster to market with all regulatory requirements completed.
Over the last 25 years, Life Science Outsourcing has become a leader in meeting specific demands of the medical device industry. We have served over 1,400 medical device companies with expanded services from our 53,000-square-foot, cutting-edge facility located in Southern California. We understand the unique needs of medical devices and have dedicated over two decades to perfecting services designed to support innovators and entrepreneurs.
Are you ready to make your next project a success? Contact us today and join the thousands of global companies who choose to be more efficient, conserve their budgets and free up their time to do what they do best while relying on us to deliver regulated services they can count on.
