AbleNet follows regulations outlined by different regulatory bodies worldwide to ensure our products are safe, abide by local laws and regulations, and privacy is honored.
We have certified our assistive technology products classified as medical devices under Europe’s Medical Device Regulation 2017/45 (MDR) and the United Kingdom’s UKCA.
Third-party laboratories test our assistive technology products to comply with CPSIA, RoHS, REACH, FCC, RED, IEC-62638, Bluetooth SIG, and shipping guidelines for lithium-ion batteries. Also, AbleNet conducts a series of tests to validate product durability and functionality.
We have implemented rigorous policies and procedures to help safeguard student or client data when funding a QuickTalker Freestyle communication device. Our policies and procedures comply with HIPAA, Medicare, and Medicaid guidelines.
All product packaging provides full disclosure about which regulatory agencies have approved or certified our products.
Before manufacturing a product, it must undergo a set of functionality and durability tests by an internal AbleNet team and pass a rigorous set of criteria that ensure product safety by a third-party test lab.
