StraxCorp’s quality assurance system is certified by BSI Global under the latest revision of ISO13485 Medical devices – Quality management systems. The Quality Management System is also designed to be in accordance with the requirements set out by the FDA under Regulation 21 CFR.820. The Strax1.0 device has been certified under the European Medical Device Directive MDD93/42/EEC, and is CE Marked 2797.
The Strax1.0 device is also listed on the TGA (Therapeutic Goods Administration) ARTG (Australian Register of Therapeutic Goods) under ARTG reference number 244571.
The Instructions for Use (eIFU) of Strax1.0 can be downloaded via this link, Instructions-for-Use-Rev-6.3.pdf
Strax HR-pQCT is FDA cleared.