The road to faster market access for your medical device
starts in our testing lab
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.
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.
It’s a fact.
Not all medical devices get the green light during the market approval process. Unfortunately, some devices get rejected before they can set out to improve and save lives.
Failing to meet regulatory standards is one of the most common reasons for rejection, forcing medical device manufacturers to return to the drawing board and repeat the lengthy and costly design process.
Such a delay in market access results in wasted time and resources without guaranteeing approval during the next round of regulatory testing.
Criterion is on a mission to change that.
With our regulatory and compliance testing expertise, our goal is to help you obtain market access for your medical device, just as we have helped our clients get their medical devices approved for marketing in no time.
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 non-conformities. Our extensive understanding of medical device standards has helped our global clients get their medical devices approved and launched in the market in no time.
We partner with medical device manufacturers to ensure their products successfully pass compliance before 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 development process and provide expert feedback.
Consulting & Testing Services
Our vast experience working with companies of different sizes and industries has allowed us to better understand and address specific requirements accordingly. We offer expert consulting and testing services with a unique perspective on compliance that none of our primary competitors have. Spending more than a decade in the testing and regulatory environment, we have acquired valuable knowledge and a deeper understanding of the medical device industry to help your product obtain market access and thrive in your field of expertise.
FDA ASCA ACCREDITATION
Criterion is FDA ASCA-Accredited for Basic Safety and Essential Performance. We are proud to be one of only three laboratories in Texas and the only one in Houston with electrical safety testing (EST) standards in our ASCA scope.
The FDA ASCA program aims to enhance the FDA's confidence in medical device testing, promote consistency in the premarket review process, and enhance regulatory efficiency and international harmonization.
Contact us today to learn how participating in the FDA ASCA program can expedite your premarket submission review.
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. At Criterion, quality comes first. We guarantee accuracy and efficiency in our recommendations to help your medical device gain market access soon and make a big difference in healthcare.
Our Satisfied Clients
" Biotex is an essential partner for any company trying to navigate the compliance testing landscape. Soon after contracting Biotex to run our compliance testing, Criterion (a Biotex service) was able to advise us on deficiencies in our paperwork and point us toward a solution, which resulted in a lower cost and faster turnaround than originally estimated. "
" Criterion did a nice job of accomplishing the packaging testing we needed, offering advice that was professional and useful. They used a combination of accomplishing the testing themselves when capable and suggesting/interacting with third-party testers when needed, overall in a relatively affordable manner. Nathan did a nice job coordinating this effort, involving others when needed. For other testing performed in the past, Nathan and Wade's expertise and guidance have been appreciated. "
Let’s Get Started
There's no need to go back to the drawing board and redesign your product. You can pass compliance and get your medical device on the market soon. That's what we're here for!