Regulatory Guiding Principles

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.