Learning Center

One-stop library for critical design, manufacturing, assembly, packaging, sterilization, validation and program management guidance tailored for Medical device manufacturers and brought to you by industry experts.

Meeting the stringent new CE mark recertification MDR requirements will take time, planning, and expertise. This is what you need to know to get started.

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

Life Science Outsourcing offers steam sterilization.

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

3 Requirements for Reliable Manufacturing Supply Chain Continuity

2024 Medical Device Supply Chain Strategies Require These Pivotal Approaches to Succeed

LSO conducting an ISTA 2A compression test on a cardboard.

ISTA Testing Standards Elevate Medical Device Packaging to Preserve your Bottom Line

LSO offers pre-validated packaging solutions.

Maximize Time and Cost Benefits with the Power of Pre-Validated Packaging for Medical Devices

LSO offers medical device assembly for combination products.

Exploring Combination Products Medical Device Assembly: Certifications Requirements and Outsourcing Solutions

A cleanroom with technicians in protective gear working on packaging reagents.

Precision Reagent Packaging Benefits, Types, and the Ramifications of Amplicons

Accelerated aging is a medical package testing method that can accurately assess packaging durability by simulating environmental factors such as heat and humidity.

Accelerated Aging: The Medical Package Testing Method that Determines Integrity, Longevity, and Reliability in Less Time

Medical device product scalability isn’t just about making more product – it’s about long-term capabilities, resources, and infrastructure. Learn more.

How Can Medical Device Companies Achieve Sustainable Scalability for Long-Term Growth?

Life Science Outsourcing Completes Acquisition of J-Pac Medical

LSO employee using microscope with computer circuit board i background

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

LSO staff operating a new 3M Steri-Vac GS8X sterilizer for enhanced medical device processing

LSO to Expand Ethylene Oxide Sterilization Capabilities in 2024

LSO welcomes Neil A. Goldman as its new Chief Financial Officer.

Neil A. Goldman Joins LSO as Chief Financial Officer

Celebrating a Decade of Excellence: Andrew Gladd’s 10-Year Anniversary at LSO

Life Science Outsourcing, Inc. Welcomes Yiorgos Polizos as Vice President of Sales & Marketing

Understanding Sterilization: Safeguarding Against Invisible Threats

A growing number of medical device innovations are introduced each year to equip medical professionals with solutions designed to enhance patient health. A critical aspect of these devices is sterilization, which ensures the eradication of pathogens to prevent healthcare-associated infections (HAIs). HAIs are prevalent in about 1 in 31 hospital patients in the United States.1 Annually, sepsis was indicated in approximately 1.7 million cases, or 6% of hospitalizations, culminating in 270,000 fatalities.2 Proactive measures, with sterilization at the forefront, are paramount for bolstering patient safety and minimizing the detrimental repercussions of HAIs.

Medical Device Packaging: Mastery of Design, Sterile Defense, and Compliance

Medical device packaging isn’t just about encasing a product – it’s an intricate balance of design, sterile barrier defense, and regulatory adherence. This white paper expands on the nuances of creating a robust medical device packaging strategy, emphasizing its purpose in safeguarding products and facilitating ease-of-use. Central to this is the critical role of the sterile barrier system, serving as the first line of defense against contaminants and pathogens.

Reduce Time to Market and Cut Costs With Pre-Validated Packaging Solutions for Medical Devices

Medical device package design can be a complex process that requires significant time and budget investments. Medical device manufacturers have increasingly turned to pre-validated packaging to mitigate such challenges. Pre-validated packaging has become a useful tool with considerable advantages over traditional custom-built packaging and can streamline the packaging process to prevent supply chain issues and deliver products to market faster, with reduced costs and fewer testing requirements.