StemExpress Equipment Validation
StemExpress offers on-site equipment validation support for our clients looking to verify that their devices meet FDA and GMP standards. Our testing process ensures full compliance and optimization of lab operations prior to product distribution. Bring your device to our state-of-the-art labs to ascertain that your equipment performs all of its intended functions with resolution and fidelity.
ON-SITE EQUIPMENT TESTING
The medical device industry relies heavily on equipment that meets rigorous standards, and performs specialized functions with precision and reliability. To assist with this process, StemExpress offers on-site equipment testing to verify your instruments are up-to-par. Clients can bring their devices to our StemExpress laboratory headquarters, where we will mimic their target lab environments using fresh material samples. As your supporting partner in equipment validation, we will help ensure that you have calibrated, accurate, reproducible research results.
PARTNER WITH US
If you need validation services for anything ranging from a tube collection to a self contained cell isolation device, we can customize protocols to support your needs. At the StemExpress lab headquarters you can bring your device in for on-site testing, where we will run freshly collected samples through your machine and report your results to you promptly. We welcome our cell therapy clients to contact us and schedule an on-site audit of our cutting-edge laboratory facilities.
- Cell collection protocols
- Cell-based equipment testing
- Blood and specimen kit development
- Research and clinical device development
- Cold chain shipping logistics
- Cell culture
- Custom vialing and cell counts
- Mobilization process
- Media and anticoagulants
- Shipping requirements