regulatory
certifications, registrations & licenses
To provide efficient information transfer to customers and distribution partners, BioHorizons provides this "Regulatory & Quality" page for interested parties to access frequently-requested documents that confirm BioHorizons certifications, registrations and licenses. Links to related websites are also provided to access additional regulatory related information.
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⋮⋮certifications, registrations & licenses
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⋮⋮MDSAP Certificate of Registration - Quality Management System - ISO 13485:2016
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⋮⋮Certificate of Registration; Quality Management System-ISO 13485:2016 & EN ISO 13485:2016
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⋮⋮FDA Establishment Registration and Listing for HCT /Ps
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⋮⋮UK HTA License
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⋮⋮Delaware Tissue Bank Registration
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⋮⋮EU Quality Management System Certificate, Regulation (EU) 2017/745, Annex IX Chapter I and III
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⋮⋮EC Certificate - Full Quality Assurance System, Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4
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⋮⋮Florida Tissue Bank
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⋮⋮Maryland Tissue Bank Permit
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⋮⋮New York Tissue Bank License
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⋮⋮Oregon Tissue Bank Registration
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⋮⋮Health Canada CTO Registration Certificate
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⋮⋮California Tissue Bank License
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⋮⋮regulatory bodies
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⋮⋮U.S. FDA | medical devices
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⋮⋮Health Canada | medical devices active licence listing
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⋮⋮UK Human Tissue Authority | licensing and inspections
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⋮⋮Australia Therapeutic Goods Administration | australian register of therapeutic goods
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⋮⋮product partners
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⋮⋮abbvie | product partner
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