If today were the big day,
is your product ready?
We’ve seen it happen. A company develops a revolutionary medical device only to be denied during market approval. The roadblock? Non-compliance with industry standards.
That's how our mission started.
Criterion aims to be the standard in product 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 an understanding of your target market's regulatory requirements and provide the testing needed to demonstrate compliance.
Here’s how it works
01
We identify the specific regulatory requirements for your product.
02
We provide you with a detailed evaluation of your product for compliance.
03
We provide you with our recommendations to address your product's non-conformities in accordance with the requirements of the standard.
04
We'll ensure we are available to respond to your questions until your product passes regulatory requirements.
Explore our testing and consulting services
Testing Services
Criterion is your dedicated team of testing and regulatory experts to ensure your medical device passes rigorous compliance testing. Our goal is to help your device gain access to the market sooner.
Consulting Services
At Criterion, we can review your product at any stage of development and provide feedback to help minimize your risk of non-conformities.
Why We’re Different
We Think
Out of the Box
Working with companies of different sizes has helped us better understand the industry. As seasoned compliance and safety testing experts, we know not all circumstances come in pre-packaged boxes. At Criterion, we're always open to discussing your unique situation, and together, we'll develop the right solutions.
We Speak
Your Language
We have a unique perspective on compliance that none of our major competitors have. We're not only regulatory and safety experts. Being a part of Biotex, we also have experience designing, developing, and manufacturing medical devices. We can address your needs more effectively because we know the industry better.
We're Small
and Personal
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 expert recommendations to help your product enter the market sooner.
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
Let's work together.
At Criterion, we are one with you in bringing a meaningful change to the world, so we can empower people, promote health, advance growth, and save lives. Let’s team up and work together to ensure your medical device passes compliance, enters the market, and becomes the catalyst for change the healthcare industry advocates.