We want our clients to know we take quality control seriously, so they can order tissues from us knowing they will receive the highest quality products available. We believe maintaining the highest certifications in the industry reflects our dedication to excellence, from providing customization options for a wide range of applications to our ability to ethically collect and process tissues.
We believe in continually raising the bar. Our commitment to providing products and services that meet or exceed our clients’ requirements is driven by our proprietary Quality Management System (QMS). Our robust system incorporates essential elements like:
- Corrective and preventive action (CAPA)
- Meticulous handling of deviations and non-conforming products
- Rigorous document and change control
- Ongoing focus on training, preventive maintenance, calibrations, and supplier qualifications
- Incorporating customer feedback
Our internal procedures lay the foundation for high quality products our customers can count on to meet their requirements, whether they’re focused on scientific research or medical device development.
The Role of Quality Certifications in Our Product Development
As a longtime supplier of the scientific and medical communities, we understand that the quality of tissues we provide directly affects the final outcome for our clients. Contamination, disease transmission, or inconsistent processing can have severe consequences, and we continually work to ensure our products meet the exacting standards required by the medical, scientific, and academic communities.
To show our dedication to our clients, we are proud to hold some of the highest benchmarks and certifications in the industry:
- ISO 13485: This international standard sets the bar for quality assurance in medical device companies. It ensures consistent safety and regulatory compliance throughout a device’s lifecycle, from design to service. Applicable to all organizations in the medical device industry, it allows for some flexibility based on a device’s nature and regulations.
- ISO 22442-2: This standard specifies requirements for medical devices utilizing animal tissues. It provides guidelines for minimizing risks associated with animal tissue use, including ensuring ethical sourcing and processing practices. This translates to a reduced risk of disease transmission and compliance with international regulations.
- FDA 21 CFR 820: These U.S. regulations mandate proper documentation, quality management, and corrective actions within the medical device industry’s quality control systems. Applied to animal tissue sourcing, it ensures traceability and accountability throughout the process. This leads to compliance with U.S. regulations and improved process control for a more reliable product.
- USDA HACCP: The Hazard Analysis Critical Control Point system focuses on food safety management. In animal tissue sourcing, it identifies and controls potential hazards throughout the process. This preventative approach safeguards the safety of animal tissues used in medical applications, minimizing contamination and disease outbreaks.
- USDA-FSIS Inspected Facilities: Facilities inspected by the U.S. Department of Agriculture’s Food Safety and Inspection Service guarantee processing meets strict hygiene and safety standards. This provides an additional layer of quality assurance, fostering trust in the high quality and safety of the animal tissues.
- APHIS Health Certificates for Exported Tissues: The Animal and Plant Health Inspection Service issues these certificates for exported animal tissues. They certify the tissues meet the health and safety standards of the importing country, facilitating international trade while upholding regulatory compliance. This ensures global standards for safety and quality, supporting market access and customer confidence.
Beyond Certification: Our Commitment to Our Clients
Regulatory requirements play a critical role in the animal tissue sourcing industry; they elevate product safety, improve quality control, and help inform risk management procedures. But it’s essential to note that we believe the cornerstone of the highest quality tissue lies in fostering a strong foundation of trust throughout our entire supply chain.
This means forging deep partnerships not only with our clients but also with the farms we source from and the facilities we use for processing. By cultivating these relationships, we ensure complete transparency and eliminate any doubt about the origin and quality of your product.
Since our founding, we’ve been dedicated to building a collaborative network across the entire supply chain. This unwavering commitment allows us to provide an unparalleled level of customization – tailoring porcine tissues to meet your exact research needs. We offer the highest quality products available, meticulously sourced and processed to your precise specifications.
Contact us today to discuss your research requirements and discover how our customized solutions can fuel your next project. We look forward to building a relationship with you for many years to come.