Ondine Biopharma Corporation Receives ISO 13485 Certification
Ondine Biopharma Corporation announced that it has achieved ISO 13485 certification, a critical step to the commercialization of its PERIOWAVE(R) product.
ISO 13485:2003 is an internationally recognized process based quality management system standard for medical devices developed by the International Organization for Standardization (ISO). ISO 13485 specifies requirements for a Quality Management System which demonstrate the organization's ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. This entails everything from staff training, customer and regulatory communication, product design and development, sourcing and purchasing of materials and services, and delivery of products and services.
The PERIOWAVE(R) photoactivated disinfection system utilizes a low-intensity red laser and light-activated compound to kill periopathogens and reduce the symptoms of periodontal disease. The compound is applied under the gum line into the affected area, and the PERIOWAVE(R) laser used to activate the compound and complete the disinfection. The patented process was developed by Professor Michael Wilson and colleagues at the Eastman Dental Institute, London, England and is licensed to Ondine by UCL Biomedica PLC, University College London.
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