Current Certifications:

ISO 13485:2012 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

UL 60601-1:2003 General Requirements for Safety and Essential Performance

Compliant with:

ISO 14971:2007 Medical Devices - Application of Risk Management

Pursuant of:

93/42/EC 2007/47/EC European Council Directive concerning medical devices
Regulatory Compliance