REGULATORY CLEARANCE FOR THE REDOXSYS® SYSTEM

In January of 2014, Aytu BioScence, Inc received ISO 13485 Medical Devices Quality Management certification — an internationally recognized quality standard for medical devices and diagnostics — for its RedoxSYS System, which covers:

  • Design
  • Development
  • Production
  • Sales
  • Service

Aytu BioScence, Inc also received ISO 9001 Quality Management certification, which sets out the requirements of a quality management system.

ISO 13485 and ISO 9001 Quality Management Certification seal

These certifications demonstrate that Aytu BioScence, Inc has successfully implemented a quality management system that conforms to the worldwide standard for medical device and diagnostic manufacturing.

EUROPEAN MARKET

CElogo

In April of 2014, Aytu BioScence, Inc obtained CE Marking in Europe for its RedoxSYS System. This regulatory clearance allows the company to engage in strategic market development activities designed to establish the utility of the RedoxSYS System in scientific and clinical research settings, and development of future clinical applications.

CANADIAN MARKET

In April of 2014, Aytu BioScence, Inc received Health Canada Class II Medical Device approval for its RedoxSYS System for assessing the level of redox imbalance in the body. The company is now engaged in discussions with potential commercialization partners, including evaluating various strategic options to maximize the commercial success of the RedoxSYS System in both global and regional distribution arrangements.

CMDCAS Recognized Registrar logo

We are actively pursuing U.S. regulatory clearance