We share a proud history with those in the medical device industry as we have tested many of the innovative medical products on the market today to ensure they perform safely and effectively. With the enactment of the U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938, the U.S. government began their oversight of medical devices. Subsequently, U.S. Congress chartered the Cooper Committee to take inventory of all medical devices currently in use. Following that review, the 1976 Medical Device Amendments were passed giving authority to the U.S. FDA to regulate medical devices. This dramatically altered the medical device industry and ultimately gave rise to Nelson Laboratories.
We are over 700 scientists, technicians, and service specialists diligently performing more than 400 rigorous tests in 11 global laboratory locations. With decades of foremost expertise, we stand behind the quality of our results and the strength of our customer partnerships.
- Biocompatibility & Toxicology – We offer a full range of material assessments using chemical characterization, in vivo and in vitro test services to meet US FDA, EU CE mark Japan MHLW and other international requirements.
- Extractables & Leachables – Our approach combines a technical and analytical expertise, polymer knowledge, understanding of regulatory requirements, all combined in a tailored approach to our customers.
- Sterilization Validations – Sterilization Validation is designed to assist the manufacturer in the development of a sterilization process that delivers the appropriate sterility assurance level and ensures repeatability for each product type developed.
- Sterility Assurance – Most tests follow United States or European Pharmacopeia (USP or EP) and similar international standards. Sterilized medical devices standards are also found in ISO, AAMI and ASTM guidance documents.
- Packaging Solutions – Our services encompass consulting, package validation, material qualification, and package development.
- Clinical Reprocessing Validations – Nelson Laboratories offers a full range of medical device cleaning, disinfection and sterilization validation services to validate manufacturers’ cleaning instructions for reusable devices.
- Facility & Process Validation – Nelson Labs offers a range of services to assess these manufacturing environmental conditions, in addition to water system validations, raw material screening and residual manufacturing material tests.
- Protective Barriers & Material Performance – Nelson Labs offers a unique combination of test services to assess these characteristics for surgical gowns and drapes as well as surgical masks and general use face masks of all types to support marketing approvals and performance label claim verification.
- Other Services & Method Development – Nelson Labs offers a number of unique tests for product verification, validation, performance testing and material properties.