Additional Testing Services
MSI provides testing services on a contract basis at our testing lab in Flagstaff, AZ. In addition to the IDTE, RX, and SR testing equipment which MSI has developed, we can complete additional tests which may be required for device evaluation and regulatory submission.
Applicable standards Include:
- ISO Standard 25539-2:2008(E) Cardiovascular Implants- Endovascular Device
- Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems – Guidance for Industry and FDA Staff – 2005
- ASTM F2394-07 for preconditioning of the stent on the deployment system prior to retention testing