Quality System

Epic Biosonics Inc. demonstrates its commitment to its products and customers through a comprehensive internal Quality System that is designed to comply with the following regulations:

• ISO 13485 2003 Medical Devices

• 90/385/EEC, Active Implantable Medical Devices (AIMD)

• 93/42/European Economic Community (EEC), Medical Device Directive (MDD)

• Title 21, Code of Federal Regulations (CFR) Part 820, Quality System Regulation (QSR).

The combination of state of the art technology, research and development, and rigorous standards for testing and quality assurance ensure that Epic Biosonics Inc. delivers long term value to the markets it serves.