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

17 Apr

Company News

Life Science Outsourcing Sets a New Standard in Medical Device Manufacturing with NIST 800-171 Compliance

Life Science Outsourcing, Inc. (LSO) has officially attained cybersecurity compliance with the rigorous standards of NIST 800-171. This accomplishment not only highlights LSO’s commitment to security and excellence but also positions the company at the forefront of the industry, typically dominated by sectors such as aerospace in terms of cybersecurity standards.

16 Feb

Medical Device Manufacturing

What do Medical Device OEMs Need to Know for MDR CE Mark Recertification in Europe?

The medical device industry is only a few years away from the MDD becoming the MDR for CE mark recertification in Europe. On average, it takes 18 months to recertify medical devices – meaning that slower-to-adopt companies may fall behind and risk losing certification altogether.

09 Feb

Sterilization & Validation

Steam Sterilization for Medical Devices: How it Works, ISO 17665, and Comparison to Other Methods

Steam sterilization is a popular medical device sterilization method that many manufacturers use to successfully prepare their devices for market and meet industry regulation standards. But is it right for your device? Learn how it works, the ISO industry standards, which devices are ideal for this sterilization method, and how it compares to other sterilization options available on the market today.