Medical Device

Female scientist examening a medical device

Infinity Laboratories has 30+ years of experience supporting medical device companies with comprehensive laboratory testing services. With coast-to-coast facilities, the Infinity team has the technologies and expertise to develop the protocols, validate and execute the tests needed for a diverse range of medical devices.

Medical Device Testing Services

Infinity combines a national provider’s state-of-the-art solutions with a local partner’s customer service. Our scientists, chemists, and site-leaders have the experience necessary to support the safety of your product.

Our one-stop testing services for your medical device support the entire product lifecycle, and they include:
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Method Development & Regulatory Support

Infinity’s expert staff has decades of experience developing phase-appropriate analytical methods and assisting in safely producing medical devices through necessary assays.

Analytical Chemistry Testing

Our experienced chemists will develop the methods and perform assays to provide high-quality data for your medical device product.

Wet Chemistry Testing

Infinity provides precise results and reliable data through a set of traditional assays characterizing elements in a liquefied sample.

Extractables & Leachables Studies

Chemical characterization studies identify potentially harmful contamination of your medical device product, identifying any undesirable effects of extractables and leachables.

510(k) Testing

A broad range of necessary analytical investigations that demonstrate that your new medical device is equivalent to another medical device currently on the market.

PMA Testing

The FDA requires Premarket Application (PMA) testing of Class III medical devices to support safety and efficacy claims before filing and use.

Microbiology Testing

Comprehensive microbiological testing to support identifying and eliminating potential contamination risks by specific pathogens, bacteria, yeast, and molds.

Sterility Assurance Testing

Comprehensive sterility monitoring and validation to support the safety of your medical device.

Gas & Water Testing

Ensure product safety and quality by identifying contamination, impurities, or lack of consistency in your gas and water supplies.

Package Testing

Safeguard your medical device from the harsh conditions of real-world distribution to assure safe delivery through multiple rounds of package and environmental testing.

Sterilization, Cleanroom & Instrumentation Services

Just as Infinity’s testing services support medical device product development, quality, and safety from early-phase development to commercialization, our team ensures effective operations and regulatory compliance with sterilization and facility support.

Our sterilization, cleanroom, environmental monitoring, and instrumentation services consist of:
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EO Sterilization

Effective sterilization of a wide range of medical devices and components using cutting-edge technologies and adhering to ISO 11135 and CFR 820 requirements.

Cleanroom Validation & Certification Services

Validate that the air supply, air distribution, filtration of air supply, materials, and procedures are regulated to meet the relevant parameters as defined by ISO 14698.

Environmental Monitoring

We partner with medical device companies to develop environmental monitoring (EM) programs that comply with FDA, USP, ISO 13485, and ISO 14698 requirements.

Laboratory & Process Instrumentation Services

Infinity supports a wide range of laboratory instruments for our medical device partners, including calibration, repair, and maintenance.
“At Infinity, we provide the capabilities and service offerings of a national organization, with the flexibility of a local lab. It’s really important to us to maintain a personal connection with our clients as we continue to fulfill our vision of becoming a single source testing services provider for the pharmaceutical and medical device sectors.”
Joe Troxell, CEO at Infinity Laboratories

Get in Touch

Want to learn more about our analytical, sterilization, cleanroom, and laboratory instrumentation services for compounding pharmacies? Connect with one of our team members today.