Quality & Compliance
Quality is how we protect every patient.
Our quality management system governs how we design, build and support every device, so it meets customer and regulatory requirements.
Quality system
Built for medical devices
Adherence to our ISO-13485 Quality Management System, with documented processes for design, manufacturing and post-market support. Quality documentation is available to customers on request.
Request quality documentationCustomer requirements
Met throughout design and production.
Regulatory standards
Followed for every product we market.
Process control
Internal measures tied to performance.
Continuous improvement
A culture, not a checkbox.
Regulatory status
eIFU
Instructions for use
Download the current IFU for each product, with revision dates. Printed copies on request.
Product safety
Report a complaint or adverse event
Contact our quality team at admin@hai-solutions.com or (833) 232-2189. You can also report to the FDA through MedWatch.