Explore the Biomaterials Ecosystem

Organizations & Support
Material & Biological Testing Test materials and devices to support an evaluation of biological risks.
Research Universities Develop bioinks and bioprinting methods to build tissue models for research.
Regulatory Review Review evidence within the applicable product and jurisdiction rules.
Standards and scheme owners Bodies that write standards or run certification schemes used in the sector.

Organizations to Explore
US Food and Drug Administration Publishes guidance for biological evaluation of medical devices.
Harvard University Develop bioinks and bioprinting methods to build tissue models for research.
NAMSA NAMSA tests biomaterials and medical devices for biological effects. Its services include chemical analysis, cytotoxicity, irritation, sensitization and other studies selected for the material and its use. It lists testing labs in the United States and Europe. A service listing does not prove that a material or finished device is safe or approved.
Nelson Labs Nelson Labs provides laboratory tests and advice for medical devices and related products. Its Salt Lake City headquarters lists biocompatibility, toxicology, extractables and leachables, material performance and sterility testing. It is part of Sotera Health. The required test and the chosen lab need a separate check; a group service list does not establish each lab’s approved scope.
Eurofins Medical Device Services Eurofins Medical Device Services tests device materials and finished devices through a network in North America, Europe and Asia Pacific. It lists biological testing, chemical analysis, extractables and leachables, and reviews of changes to materials or manufacturing. This entry describes Eurofins services, not blanket approval of a device or every laboratory’s scope.

How They Connect
Material & Biological Testing — Material & Biological Testing Outputs Output: Material & Biological Testing Outputs.
Research Universities — Research Universities Outputs Output: Research Universities Outputs.
Regulatory Review — Regulatory Review Outputs Output: Regulatory Review Outputs.
Research Universities — Bioprinting Uses: Bioprinting.
Bioprinting — Research Universities Outputs Method for: Research Universities Outputs.
Hydrogels, Bioinks & Matrices Outputs — Research Universities Outputs Feeds into: Research Universities Outputs.

Products & Services
Material & Biological Testing Outputs Test results for device developers and reviewers.
Regulatory Review Outputs Guidance and regulatory review for product developers.
Research Universities Outputs Research results and trained staff for science and industry.
Hydrogels, Bioinks & Matrices Outputs Bioinks and matrices for research teams.

Methods & Technologies
Bioprinting Uses bioinks to build research constructs.

Sources
CELLINK: Bioink Describes a polysaccharide bioink and its research-use restriction.
Eurofins Medical Device Services official role and services Read the source for scope and details.
Eurofins Medical Device Services official role and services Read the source for scope and details.
NAMSA official role and services Read the source for scope and details.
Nelson Labs official role and services Read the source for scope and details.
Nelson Labs official role and services Read the source for scope and details.
FDA: Biological Evaluation of Medical Devices Explains risk-based biological evaluation of device materials; material data alone do not approve a device.
Harvard Lewis Lab: Research Describes bioinks and bioprinting for tissue models and drug testing.