Signature Process

Using our proprietary Signature Processing techniques and following minimally manipulative procedures, our process does not alter the regenerative properties of the placental tissue. Our products maintain the integrity of the original source material and the relevant characteristics relating to its utility for soft tissue supplementation that is required for tissue repair.

  • All products undergo independent sterility testing and are manufactured in a GMP & GTP Facility.
  • Signature Cord, Signature Matrix, and Signature APatch are HCT/P compliant under Section 361 of the Public Health Service Act according to 21 CFR Part 1271.10. They are regulated as a human cell and tissue product – for homologous use only.
  • Prescription use only for sale to licensed healthcare professionals.

CERTIFIED
QUALITY
MANAGEMENT
SYSTEM

ISO 9001:2015 specifies requirements for a quality management system when an organization needs to demonstrate an ability to consistently provide products and services that meet customer and regulatory standards. Signature Biologics’ quality management system is ISO certified and surpasses regulatory requirements to meet our own high quality standards.

ISO certification

ACCREDITED
TISSUE
BANK

The American Association of Tissue Banks (AATB) is a professional, non-profit, scientific and educational organization that requires a rigorous set of criteria be met for AATB-accreditation. Signature Biologics is accredited for numerous tissue processing techniques and procedures. Our accreditation number and list of accreditations can be found by clicking the link below.

AATB Accreditation

STANDARDS
PROCESS
CONTROLS

Current Good Manufacturing Practices (cGMP) and Current Good Tissue Practice (cGTP) employed at Signature Biologics assure that the products are of consistent quality, free from contamination, and protect the recipient from harm. These practices also ensure that staff is well trained, documentation is thorough, and numerous quality checks are performed during the manufacturing process.

CERTIFIED
QUALITY
MANAGEMENT
SYSTEM

ISO 9001:2015 specifies requirements for a quality management system when an organization needs to demonstrate an ability to consistently provide products and services that meet customer and regulatory standards. Signature Biologics’ quality management system is ISO certified and surpasses regulatory requirements to meet our own high quality standards.

ISO certification

ACCREDITED
TISSUE
BANK

The American Association of Tissue Banks (AATB) is a professional, non-profit, scientific and educational organization that requires a rigorous set of criteria be met for AATB-accreditation. Signature Biologics is accredited for numerous tissue processing techniques and procedures. Our accreditation number and list of accreditations can be found by clicking the link below.

AATB Accreditation

STANDARDSPROCESSCONTROLS

Current Good Manufacturing Practices (cGMP) and Current Good Tissue Practice (cGTP) employed at Signature Biologics assure that the products are of consistent quality, free from contamination, and protect the recipient from harm. These practices also ensure that staff is well trained, documentation is thorough, and numerous quality checks are performed during the manufacturing process.