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Innovative Medical Device Assembly

Life Science Outsourcing is an FDA-registered and ISO 13485-certified, performance-driven Contract Manufacturing Organization. We streamline end-to-end processes in assembly, packaging, sterilization, and microfluidic packaging and design, leveraging our deep regulatory knowledge to accelerate OEM launches and mitigate risk.

Your Partner in Innovation

Life Science Outsourcing’s Medical Device Manufacturing services offer a turnkey solution for medical and pharmaceutical start-ups as well as original equipment manufacturers. With more than two decades of experience, our manufacturing and engineering experts work as an extension of your team, turning ground-breaking concepts into commercial-ready products.

We are ISO 13485:2016-certified and FDA-registered with 10,000 square feet of state-of-the-art Class 10,000/ISO 7-rated cleanroom space.

Services and Expertise

Our turnkey medical device manufacturing solutions help clients plan, construct, and commercialize products with unwavering precision and partnership. Our processes are purpose-built to navigate complex regulatory environments and tight turnaround times that can derail business plans and profitability.

Manufacturing Specialties

From precision assembly and testing to complex supply chain sourcing and planning, our manufacturing services offer targeted expertise and execution in exceptional environments.

  • Catheter Assembly
  • Electromechanical Assembly
  • Combination Products

Engineering Specialties

From process development and validation to packaging design and development, our engineering solutions deliver a blueprint for bringing the next generation of medical and pharmaceutical innovations to market.

  • Process Development
  • Tooling
  • Documentation

Industries We Serve

Orthopedic

Orthopedic

Inspection, cleaning, sterile and non-sterile kitting, product assembly, sterile and non-sterile packaging, and sterile and non-sterile repackaging

Biopharmaceutical

Biopharmaceutical

Certified class 100 and/or class 10,000 environments for the processing and packaging of biomedical, biological, and pharmaceutical products

In Vitro Diagnostic

In Vitro Diagnostic

Filling and capping processes, assembly, labelling and traceability, and sterilization

Capabilities and
Processes

Our services are built on the ability to design and execute highly specific and technical manufacturing processes. Over the past 25 years, we’ve refined our capabilities to ensure every step provides maximum efficiency in cost and time to market while meeting or exceeding all regulatory requirements.

  • Bonding Processes
  • Mixing and Filling
  • Packaging
  • Soldering
  • Ultrasonic Welding

Don't take our word for it!

Frequently Asked Questions

We’re committed to helping medical device manufacturers find the answers and solutions they need to bring their innovations to life quickly and efficiently. Get answers to the most common questions for Cleaning & Decontamination and all our services.

From Idea to Commercialization

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