Regulatory Guiding Principle

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.
• AbleNet has achieved SOC 2 Type II compliance in accordance with American Institute of Certified Public Accountants (AICPA) standards for SOC for Service Organizations (SSAE 18). This third-party validation confirms that AbleNet provides enterprise-level security for customer data, with controls that are tested and proven to operate consistently over time.
• AbleNet has achieved the Award of Accreditation from the Healthcare Quality Association on Accreditation (HQAA).  This three-year accreditation is achieved after completing a comprehensive application focused on patient care, financial stability, and a commitment to quality operational practices and procedures.
• AbleNet has achieved certification to ISO 13485:2016, the internationally recognized standard for medical device quality management systems that the FDA incorporated by reference into its Quality Management System Regulation (QMSR) effective February 2, 2026. Independently audited and certified by Perry Johnson Registrars, Inc. on April 10, 2026, this certification confirms that AbleNet’s design, development, configuration, and distribution of the QuickTalker Freestyle Speech Generating Device are managed under a controlled, reliable, and compliant quality management system designed to ensure delivery of quality products that meet customer and regulatory expectations.
• 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.