Traceability
Distribution and inventory processes are intended to support product identification and lot-level traceability throughout our distribution operations.
Quality is a chain of responsibility.
Human tissue products require care at every stage, from donor screening and processing through packaging, storage, distribution and delivery. Evologics takes that responsibility seriously.
Trust requires process.
Quality depends on a series of documented processes and responsible organizations working together throughout the product lifecycle. Evologics evaluates products and partners with attention to product quality, regulatory status, tissue processing practices, documentation, storage requirements, traceability and distribution.
Understanding the regulatory framework.
Human cells, tissues and cellular and tissue-based products, commonly referred to as HCT/Ps, are regulated by the U.S. Food and Drug Administration under frameworks that depend on the characteristics and intended use of the individual product.
Regulatory information is communicated by Evologics on a product-specific basis. FDA registration or product listing does not mean that a product has been approved, cleared, certified or endorsed by the FDA.
Accreditation in progress
Advancing our quality systems.
Evologics is currently completing the AATB accreditation process.
Responsibility continues through delivery.
Storage and handling
Distribution processes are designed around the requirements established for each product, including appropriate storage conditions, inventory controls and shipping procedures.
Transparent communication
Product characteristics and clinical descriptions should remain consistent with the regulatory pathway, labeling and evidence applicable to the specific product.
Questions deserve documentation.
Healthcare partners may contact Evologics for available product-specific regulatory, quality, processing, storage and handling documentation.
- Instructions for Use
- Product specifications
- Regulatory information
- Processing information
- Storage and handling information
- Certificates
- Available supporting quality documentation