Criterion
Testing Services

Criterion aims to be the standard in product and compliance testing. We also strive to exceed our clients' regulatory needs.

Criterion aims to be the standard in product and compliance testing. We also strive to exceed our clients' regulatory needs. As compliance and safety experts with years of experience testing and evaluating medical devices, we are committed to helping medical device manufacturers like you obtain market access for your product. As the testing services arm of Biotex, Inc., a premier medical device development and manufacturing company with more than twenty years of success in the industry, Criterion has vast resources far beyond your typical test laboratory.

At Criterion, our goal is to save you time and resources and eliminate the costly redesign process. We'll review your product at any stage of development to ensure understanding of the target market regulatory requirements and provide the testing needed to demonstrate compliance.

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What we bring to the table

At Criterion, we can review your product at any stage of development and provide feedback to help minimize your risk of nonconformities. Our robust and proven Quality Management System has helped our global clients get their medical devices approved and launched in the market in no time.

 

Biomedical Compliance Testing in Houston, TX

 

Compliance Expertise

We partner with medical device manufacturers to ensure their products successfully pass compliance during the rigorous market approval process. We can help you, too. Whether you already have an existing medical device that must pass safety and compliance testing or are still in the initial stages of development, our team will support you through every step. As part of our strategy, we’ll review your product at any stage of the compliance process and provide expert feedback.

 

Biomedical Compliance Testing in Houston, TX

 

Consulting & Testing Services

Working with companies of different sizes has helped us better understand the industry. We have a unique perspective on testing and compliance that none of our major competitors have. We're not only regulatory and safety experts. We also design, develop, and manufacture medical devices. We can address your needs more effectively because we know the industry better.

 

Biomedical Compliance Testing in Houston, TX

 

ISO 17025 AccreditATION

We are ISO 17025 accredited. Entrusting your product to our team of experts for safety and compliance is one of the best investments you can make to succeed as a trusted medical device company. Our small size works to your advantage as we conduct our business with a personal touch. We're accessible and ready to help without the unnecessary channels, paper trail, long queues, and wait time. We guarantee quality, accuracy, and efficiency in our recommendations to help your medical device enter the market sooner.

Services

Let Criterion be your dedicated team to ensure your medical device passes rigorous compliance testing and gains access to the market. Choose from our standard consulting and testing services. If your need is unique, we can create a customized service just for you.

 

 

Packaging Performance Studies

Packaging performance studies consist of a simulated transport and delivery test sequence followed by package integrity testing. This type of study is used to demonstrate the packaging system provides adequate protections to all sterile barrier systems through the hazards of handling, distribution, and storage.

 

 

ELECTRICAL SAFETY TESTING (EST)

Our team has extensive experience in the IEC 60601 series of standards for medical electrical equipment. Whether you need consulting services, standards interpretations, pre-testing, debugging, or a complete compliance evaluation, we are here to help.

 

 

STABILITY STUDIES

Determining the shelf life is critical for sterile medical devices. It is required by ISO 11607-1, which states, "packaging systems shall maintain sterility until the point of use or the expiry date." The expiry date or the shelf life is established through a stability study. Stability studies consist of an accelerated aging or real-time aging study followed by package integrity testing. In addition to evaluating the integrity of the packaging system over time, stability studies can be used to assess the performance of the device over time as well.

 

 

ELECTROMAGNETIC COMPATIBILITY (EMC)

A critical hurdle for any electronic medical device is demonstrating compliance with the IEC 60601 series of standards, including IEC 60601-1-2 regarding Electromagnetic Compatibility (EMC). Whether you need consulting services, standards interpretation, pre-testing, debugging, or a complete compliance evaluation, we are here to help.

 

 

STERILE BARRIER INTEGRITY TESTING

Maintaining sterility is critical to ensuring a medical device is safe for use. Sterile battier integrity testing is a critical part of the sealer qualification, performance study, and stability study to validate a sterile barrier system.

 

 

ENVIRONMENTAL CONDITIONING

During environmental conditioning, the test items are subjected to different levels of temperature and humidity, representing the other environmental extremes the final marketable product may be subjected to throughout its shelf life.

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the criterion advantage


  • Saves you time and resources
  • Helps drive the design of your product
  • Minimizes the risk of non-conformities
  • Prevents the lengthy & costly redesign process
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Contact Us


  • Biotex, Inc.
  • Attn: Criterion
  • 114 Holmes Rd,
  • Houston, Texas 77045
  • Call +1-713-741-0111
  • FAX +1-713-741-0122
  • EMAIL criterion@biotexmedical.com

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