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Evologics America

Tissue Safety Is a System, Not a Checkbox

Hospitals need product-specific information that supports supplier evaluation, storage and handling, tissue traceability, recall response, and investigation of quality concerns.

Available Quality and Compliance Resources

  • FDA tissue establishment registration information
  • Applicable state licenses
  • Accreditation certificates, when applicable
  • Donor eligibility statements
  • Processing summaries
  • Sterilization information
  • Certificates of conformance or analysis, when available
  • Package labels and instructions for use
  • Storage and handling requirements
  • Shelf-life and expiration information
  • Lot, serial, donation, or distinct identification information
  • Tissue tracking forms or instructions
  • Recall and market-action procedures
  • Product complaint procedures
  • Adverse-event reporting contacts
  • Manufacturer or processor contact information

Important information

Supporting Bidirectional Traceability

Product labels and accompanying records may contain identifiers needed to connect a distributed tissue product with applicable donor and processing records. Hospitals remain responsible for maintaining their institutional tissue-management and recipient-tracking systems. Evologics can help identify product information and coordinate documentation for investigation, recall response, or final-disposition reconciliation.

Storage and Handling

Storage requirements vary across the Evologics portfolio. Products may be stored at ambient, refrigerated, frozen, or other controlled conditions according to their labeling. Always follow the instructions supplied with the individual product.

Product Concerns

Do not use a product when packaging integrity, labeling, storage history, shipment condition, or product integrity is uncertain. Quarantine it according to facility policy and contact Evologics promptly.

Quality Documentation

Quality and RegulatoryPDFAvailable by request

Quality and Regulatory Document Index

Index of available registrations, licenses, accreditations, quality certificates, labels, and processor documents.

Quality and RegulatoryPDFComing soon

Tissue Establishment Registration Index

Product-to-processor index with links or references to applicable FDA tissue establishment information.

Product InformationPDFComing soon

Storage and Handling Matrix

Product-specific storage categories, shelf-life references, receiving checks, and handling-document links.

Quality and RegulatoryPDFComing soon

Tissue Tracking and Disposition Guide

General guidance for identifying product tracking fields and routing disposition documentation. This is not a substitute for hospital policy.

Quality and RegulatoryPDFComing soon

Product Complaint and Quality Concern Guide

Contacts and information needed when reporting packaging, labeling, shipment, storage, or product-integrity concerns.

Quality and RegulatoryPDFComing soon

Recall and Market Action Guide

Hospital contact pathway and general response process for affected product notifications.

Important information

Time-Sensitive Case or Product Quality Concern

Do not use a product when its packaging, labeling, storage history, condition, or integrity is uncertain. Quarantine it according to facility policy and contact Evologics promptly.

Information provided within the Evologics Hospital Resources section is intended for general educational and operational purposes. Product availability, regulatory status, processing, storage requirements, shelf life, labeling, and instructions vary by product. Healthcare professionals must review and follow the labeling and instructions supplied with each product. Nothing on this website replaces institutional policy, professional judgment, applicable law, or consultation with qualified legal, regulatory, reimbursement, or clinical advisors. Products should only be used for purposes consistent with their applicable labeling and regulatory status.