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Life Science Outsourcing’s veteran team of experts shares cutting-edge resources, regulatory insights, and partner-ready solutions.
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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.
Gas chromatography system used for EO residual testing of sterilized medical devices in a modern laboratory environment.
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.
A laboratory technician in cleanroom attire conducts a quality control inspection with a clipboard and pen in a sterile facility.
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.
Gloved technician drawing liquid from sterile vial into syringe in cleanroom environment
Sterilization & Validation

Few and Far Between: Why CDER-Certified Steam Sterilization—and the Experts Behind It—Matter for Combination Product OEMs

Sterilization is a critical step for injectable and combination products—but few providers are certified by FDA’s CDER to perform it. This blog explains what CDER certification means, why certified steam sterilization is rare, and how in-house capacity and technical expertise help OEMs avoid delays, ensure compliance, and streamline the path to market.
Close-up of a gloved hand holding a petri dish with microbial colonies growing on agar, used for bioburden testing in laboratory environments.
Sterilization & Validation

Is Vaporized Hydrogen Peroxide (VH2O2) the Right Sterilization Method for Your Medical Device? 

Find out if VHP sterilization is suitable for your medical devices and explore alternatives for optimal sterilization results.
Life Science Outsourcing offers steam sterilization.
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.
3M Steri-Vac chamber processing a small batch of EtO at Life Science Outsourcing.
Sterilization & Validation

The Strategic Advantages of Localized Ethylene Oxide Sterilization Services for Medical Devices

Medical device companies: Have you experienced sterilization setbacks resulting from stricter EtO regulations and need a local provider? These regulations have increased turnaround times for products to be sterilized via EtO in recent years, causing various delays and loss of revenue for companies just like yours. Fortunately, there IS a solution to address these challenges! Read our new blog to learn more.
3M Steri-Vac chamber processing a small batch of EtO at Life Science Outsourcing.
Sterilization & Validation

3 Important Ethylene Oxide Sterilization Questions: What Medical Device Companies Need to Know

Medical device companies looking for a contract ethylene oxide sterilization partner must be aware of the latest regulations surrounding EtO impact to the environment, technicians and end users. Yet these three critical questions are often missed. Find out what they are in our new blog..

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