Quality and Safety
RegenMed is dedicated to upholding the highest standards for the safety of donated human tissue for transplant. We aim to be a leader in the Canadian tissue banking industry by providing the safest and cleanest sterile allografts. This is achieved by comprehensive donor screening and testing, as well as utilizing special methods validated to sterilize the tissue.
RegenMed is currently registered with Health Canada as a Cells, Tissues and Organs for Transplantation (CTO) Establishment. We take pride in meeting or exceeding Federal CTO Regulations as well as Canadian tissue banking standards. RegenMed is currently focused on achieving accreditation from the AATB (American Association of Tissue Banks)
Quality
♦ Tissue Processing
- Environmentally controlled clean rooms
- Validated sterile processing methods
- Validated packaging
- Validated freeze-drying methods
♦ Storage and Shipping
- Continuous monitoring of storage temperatures for frozen tissue
- Validated containers for frozen tissue shipping
♦ Standards and Regulations
- Health Canada registered and compliant
- AATB standards implemented
♦ Tissue Safety
- Donor suitability determined by Medical Director
- Tissue released for distribution following rigorous technical and quality review
♦ Quality System Highlights
- Quality Manual modeled after ISO 9001
- Standard Operating Procedures Manual
- Document Control
- Quality Improvement Program
- Supplier Qualification and Audit
- Staff Training and Competency Assessment
- Internal Audits
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