Quality & Compliance

Complete traceability from tissue source through final product. Each batch is documented with full processing records and quality testing data.

Multiple quality parameters are verified for each production batch.

• DNA quantification to international standards
• Bioactive component retention analysis
• Structural integrity verification
• Bioburden testing
• Endotoxin assessment

Our facility in Hangzhou, China operates under GMP principles with classified cleanroom environments (Class 100,000 / Class 10,000 / local Class 100) appropriate for biomaterial processing.

Our quality management system is established in reference to ISO 13485. Every batch is accompanied by a Certificate of Analysis (CoA) covering key parameters including DNA residue, GAG retention, and structural integrity — ensuring full traceability and comparability.

We understand that ECM materials may be subject to various regulatory frameworks depending on the intended use and region. We provide documentation to support our partners' regulatory submissions but do not make specific regulatory claims for our raw materials.

Regulatory classification and requirements vary by intended use and jurisdiction. Partners are responsible for determining applicable regulatory requirements for their specific applications.