Bringing Medical Innovations

TO LIFE

Life Science Outsourcing is a performance-driven contract manufacturer helping medical device and pharmaceutical innovators start up, speed up, and scale up.

Your Trusted Partner for Over 25 Years

Life Science Outsourcing has partnered with more than 1,400 medical device innovators to streamline production and navigate complex regulatory requirements. We help innovators successfully enter and expand into new markets and accelerate revenue.

Services and Expertise

Start up. Speed up. Scale up. Founded in 1997, Life Sciences Outsourcing was born of a need to enhance and advance medical innovation. We are an FDA-registered and ISO 13485-certified organization with services and capabilities spanning the entire medical device product life-cycle – from turnkey manufacturing, testing, validation, and sterilization to precision packaging, fulfillment, and distribution.

Each service is purpose-built to deliver proven solutions at the most critical points in the product development process, reducing costs and accelerating time to market.

One-Stop Shop

From Idea to Commercialization

From startups to multinational corporations, we’ve helped pharmaceutical companies and medical device makers of all sizes turn powerful ideas into profitable offerings. Our unique model serves as a turnkey solution offering unparalleled time to market through a full spectrum of regulated services and specialized high-value capabilities.

Case Studies

We’ve helped clients across the medical device space plan and commercialize innovative new solutions. Read more details about how our partnerships empowered these companies’ success.

Agile and Flexible

Deeper Partnership

We act as an external extension of client teams with the depth and expertise to guide, support, and adapt to evolving needs at every turn. With onboarding in as little as one week, our work with clients is rooted in collaboration and shared objectives.

Regulatory Expertise

Proven Results

With decades of hands-on experience, our veteran teams guide clients through the regulatory and commercialization process to mitigate risk, minimize delays and speed up time to market and revenue.

We have been extremely impressed with LSO’s responsiveness, integrity, technical knowledge, attention to detail, passion for schedule and value. They surpass many of the larger more well known labs in all of these categories. LSO is our new go-to vendor for laboratory services!

Knowledgeable team, prompt, professional service and a great partner for startup medical device companies. I would recommend LSO to my colleagues.

...the team at LSO have been great to work with. Their decades of experience in packaging, sterilization, and validation, helped us accelerate the release of our medical device in record time.

Case Studies

We’ve helped clients across the medical device space plan and commercialize innovative new solutions. Read more details about how our partnerships empowered these companies’ success.

News & Info

04 Jun

Company News

How Do You Speed Up Commercialization Without Compromising Compliance? Visit LSO at OMTEC 2025

Orthopedic OEMs are under growing pressure to move faster without compromising compliance. At OMTEC 2025, LSO will showcase how consolidating packaging, sterilization, and cleanroom assembly under one roof helps eliminate delays and accelerate commercialization. Visit us at Booth 350—or schedule time with our team whether you’re attending or not.

23 May

Sterilization & Validation

What Is Ethylene Oxide (EtO) Residual Testing and Why It Matters for Medical Devices

EtO residual testing ensures that your ethylene oxide sterilized medical device is safe for use and compliant with ISO 10993-7 and FDA requirements. Because patient safety and regulatory submissions depend on accurate chemical residue analysis, EtO residual testing should be a non-negotiable part of your sterilization validation strategy.

19 May

Sterilization & Validation

How Often Should You Perform Bioburden Testing? A Risk-Based Approach

Bioburden testing should never be reduced to a set-it-and-forget-it calendar task. It is a living part of your quality system and a primary indicator of your microbial control status. While quarterly testing is a good starting point for many manufacturers, a truly risk-based program requires ongoing evaluation.