It is the foundation of how we develop, manufacture, and deliver regenerative biomaterials. Recognized standards establish the baseline; our internal expectations go further.
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QUALITY & COMPLIANCE
Built on Quality. Backed by Compliance.
SigmaGraft is committed to rigorous global standards that support product safety, quality, and traceability.
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Quality System
ISO 13485 aligned
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Traceability
Internationally recognized
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Traceability
Controlled throughout
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Patient Safety
Our highest priority
OUR COMMITMENT
Quality is more than a requirement
01
Safety First
Patient safety and product integrity guide our decisions at every stage.
02
Controlled Processes
Documented systems support consistency, traceability, and reliable performance.
03
Continuous Improvement
We continually evaluate and strengthen our processes, training, and quality culture.
OUR STANDARDS
A globally aligned quality system.
It is the foundation of how we develop, manufacture, and deliver regenerative biomaterials. Recognized standards establish the baseline; our internal expectations go further.
ISO
Quality Management
ISO 13485
We follow internationally recognized quality management system requirements for medical device manufacturing.
MDSAP
Global Audit Readiness
Medical Device Single Audit Program
Our quality system supports the regulatory requirements of the United States, Canada, Brazil, Japan, and Australia.
AATB
Tissue Banking
AATB Tissue Banking Standards
We follow tissue banking standards for the responsible processing, storage, and distribution of donated human tissue.
ASTM
Testing & Characterization
ASTM, USP & ISO Standards
Testing and product characterization are performed in accordance with applicable ASTM, USP, ISO, and other recognized standards.
Regulatory Compliance
Designed to Meet Requirements Worldwide
We maintain controls that support product safety, traceability, and compliance across the markets we serve.
FDA 21 CFR Part 820
We follow current good manufacturing practices to help ensure medical devices distributed in the United States are consistently manufactured for safety and performance throughout their life cycle.
FDA 21 CFR Part 1271
Our donor screening, processing, manufacturing, storage, and distribution practices are designed to reduce the risk of disease transmission and protect product safety.
International Regulations
Products reaching more than 30 countries are supported by compliance with applicable local and national requirements across the European Union, South Korea, Mexico, Colombia, Saudi Arabia, and other markets.
Safety & Responsibility
We comply with applicable local, state, and federal requirements related to employee safety, environmental responsibility, and responsible operations.
Beyond Compliance
A Higher Standard, centered on patients.
Compliance defines what is required. Our responsibility is to continually strengthen the systems, processes, and culture that protect every patient touched by our products.
- Product safety at every step
- Traceability from source to use
- Integrity in every decision
- Continuous quality improvement
TRUSTED PARTNERSHIPS
Let's Build Better Outcomes—Together.
We collaborate with healthcare professionals, distributors, and industry partners who share our commitment to quality.