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Safety
Bone graft substitutes based on demineralized bone matrix technology have been used in clinical medicine for more than 10 years. IsoTis has a long history in medical device manufacturing, and complies with the U.S. Food and Drug Administration’s Good Manufacturing Practices. IsoTis’ products have been used in more than 250,000 patients safely and effectively.
IsoTis fully complies with the ISO 13485:2003 Quality Management System, the most exacting quality management standard for medical devices. IsoTis is also accredited by the American Association of Tissue Banks (AATB), and has a Tissue Bank License covering its operations in California, Florida, New York, Maryland.
If you have any questions about the use and safety of our products, please do not hesitate to contact us. |
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