We understand the challenge of sourcing tissue/animal-derived collagenous biomaterials to meet the quality and regulatory requirements of even the largest global medical device manufacturers.
- Quality management system certified to ISO 13485 Quality System for Medical Devices and ISO 22442-2 Medical Devices utilising animal tissues and their derivatives
- Personnel dedicated to supplier relationship management, on-site training, and abattoir audits
- Animals sourced to meet tissue thickness and other characteristics according to individual customer specifications
- Capability to manufacture processing and shipping solutions, either to customer specification or to our own formula
- Established logistics chain from multiple qualified suppliers using validated temperature controlled insulated shipping boxes and coolers
Biomaterials Risk Management
Sourced directly from multiple geographies including Australia, New Zealand, and United States with traceability to birth. Multiple abattoirs reduce risk and provide flexible capacity
Carefully harvested, defatted & closely inspected for holes or tears, delamination & blemishes to ensure tissue meets specifications
Shipped via airfreight direct from abattoir to meet client times and protocols, including validated temperature-controlled packaging
We source materials only from qualified and approved abattoirs. These abattoirs adhere to strict environmental controls and husbandry practices, and judiciously manage animal traceability. Only animals certified fit for human consumption are used. Collagen Solutions maintains formal quality agreements with all our abattoirs. We manage the relationship with source plants and develop tissue collection protocols for each material in collaboration with our customers. We train and monitor professionals in plants and work closely with these teams. Collagen Solutions has a formal audit program in place and we facilitate customer audits as required.