Trusted xeno tissue materials for medical device developers.
Reliable by nature. We process decellularized and cross-linked bovine and porcine pericardium under a certified quality system, for medical device developers building their own cleared products.
Three service tiers, one quality system.
SokoLife operates as a contract manufacturer of biological tissue materials. We do not market end-use indications. Material specifications and processing parameters are described below; clinical use is determined by our customers under their own regulatory submissions.
Decellularized pericardial matrix
Bovine and porcine pericardium processed to remove cellular components while preserving the extracellular collagen architecture. No aldehyde chemistry used in the decellularization pathway.
Glutaraldehyde-fixed pericardium
Bovine and porcine pericardium stabilized with glutaraldehyde cross-linking. Supplied as flat sheets in stock and custom dimensions for downstream device assembly by qualified manufacturers.
Contract manufacturing
Bench-to-pilot tissue processing services for device developers: feasibility, protocol development, custom geometries, and reporting against your design controls.
Specification sheets.
Material data published here is informational. SokoLife does not state, suggest, or imply use of any of these materials for any specific clinical indication. Indication-of-use is the responsibility of the device sponsor.
Decellularized pericardial extracellular matrix.
Bovine and porcine variants. Closed-herd US sourcing for bovine tissue. Processed without aldehyde chemistry to preserve native collagen architecture and reduce immunogenic load.
Sourcing
- BovineUS closed-herd · WOAH controlled-risk BSE classification · Animal age 6 – 24 months
- PorcineControlled-environment herds with documented health monitoring
- StandardsAAMI / ISO 22442-2 traceability and risk management
Processing
- ChemistryNo aldehyde chemistry at any step of the decellularization pathway
- Cellular DNA< 50 ng/mg dry weight (specification)
- α-Gal residueReduced via standardized wash protocol
Physical specifications
- Thickness0.15 – 0.75 mm
- SurfacesSmooth (serous) and villous (fibrous) faces, both labeled
- Stock sizes5×5, 6×8, 5×10, 8×4, 8×8, 6×12, 10×10, 12×10 cm
- CustomGeometries and tolerances on request under MSA
Glutaraldehyde-fixed pericardium.
Bovine and porcine pericardium stabilized through controlled glutaraldehyde cross-linking. Supplied in buffered storage for handling by downstream device manufacturers.
Sourcing
- BovineUS closed-herd · WOAH controlled-risk BSE · Age 6 – 24 months
- PorcineControlled-environment herds with documented health monitoring
- TraceabilityLot-level chain of custody from harvest to release
Chemistry
- Cross-linkGlutaraldehyde, controlled concentration and time
- StorageBuffered solution, hermetically sealed primary package
Physical specifications
- Thickness0.15 – 0.75 mm
- Stock sizes5×5, 6×8, 5×10, 8×8, 6×12, 10×10 cm
- CustomCut-to-size and shaped geometries available under MSA
Contract manufacturing & process development.
Engagement model for device developers who need tissue material processed against their own design controls and held under our quality system.
Engagement scope
- FeasibilityMaterial screening and proof-of-concept lots against your acceptance criteria
- DevelopmentProcess and protocol development; tailored chemistry within validated envelopes
- Custom geometryDimensions, shapes, and surface labelling on request
- DocumentationLot release records, process reports, traceability outputs
Quality posture
- QMSISO 13485:2016 certified manufacturing facility
- StandardsAAMI / ISO 22442-2 for animal tissue source control
- IPCustomer retains full ownership of developed product specifications
Quality system, sourcing, and traceability.
ISO 13485:2016 certified quality system.
The SokoLife facility operates under a certified medical device quality management system. Documented procedures govern incoming inspection, process control, lot release, and traceability for every shipment.
WOAH-classified tissue sourcing.
Bovine tissue is sourced from herds in regions classified by the World Organization for Animal Health as having a controlled risk of BSE. US closed-herd documentation is maintained at the lot level.
ISO 22442-2 traceability framework.
Animal tissue control, risk management, and traceability documentation is maintained against AAMI / ISO 22442-2, allowing customer device sponsors to incorporate SokoLife inputs into their own regulatory submissions.
SokoLife, Inc.
A biomaterials company in Eugene, Oregon, operating an ISO 13485-certified facility for processing animal-source connective tissue. We work behind the scenes for medical device developers who need disciplined materials science and a documented quality system.
Open a project, request a spec sheet, or visit the facility.
Project inquiries
SokoLife, Inc.
Eugene, Oregon 97403
United States