Quality comes first
Obtaining approval to market requires accuracy, stability, and reliability from your medical device. That makes your lab's testing, assessment, and recommendations crucial to the success of your product. At Criterion, we uphold quality and accuracy in our testing and consultation services to ensure your device gets approved for regulatory compliance and gains market access 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
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 protection to the medical device and any sterile barrier systems from the hazards experienced during handling, distribution, and storage.
ELECTRICAL SAFETY TESTING (EST)
A critical hurdle for any electronic medical device is demonstrating compliance with IEC 60601 series of standards regarding Electrical Safety Testing (EST). We'll ensure your medical device is compliant with all applicable 60601 standards, providing accurate results and expert recommendations.
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 a real-time aging study followed by package integrity testing. Manufacturers may choose to perform an accelerated aging study to establish the expiration date while waiting on the real-time aging results. 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)
Another crucial step to passing compliance requires complying with the IEC 60601-1-2 through Electromagnetic Compatibility (EMC). Whether you need consulting services, standards interpretation, pre-compliance 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 barrier integrity testing is a critical part of the sealer operation/performance qualification and packaging performance and stability studies 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.