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Medical Device - Toxicology, Biocompatibility, Sterility, Microbiology Testing

Medical Devices

Several steps are required in the development of a medical device from the concept phase to full-scale production. The actual number of steps may vary according to the novelty and complexity of the finished product. However, the development process is nearly always multidisciplinary, and includes checkpoints for testing and validating the new device and its component materials aside from functionality and performance testing. There are three areas of biomedical laboratory investigation that are of key importance in the development process: Chemistry, Microbiology, and Toxicology.

NUCRO-TECHNICS has the capabilities to assist in all areas in the selection and timing of appropriate test methods for evaluating medical devices. Typical testing programs involve appropriate combinations of routine tests as shown below:

Phase I: Raw Material Characterization and Screening
  • Cytotoxicity
  • Physicochemical Tests
  • Infrared Identification
Phase II: Material Biocompatibility (Per FDA / AAMI and ISO)
  • Acute & Chronic Toxicology
  • Hemocompatibility Studies
  • Mutagenicity Testing
Phase III: Product & Process Validation
  • Microbiological Evaluation
  • Sterilization Cycle Validation
  • LAL / Particulate Analysis
Phase IV: Routine Testing
  • Finished Product Qualification
  • Release Testing
  • Audits

Several methods of analysis are available. The choice of an appropriate method is often influenced by the intended end use of the product and may warrant consultation between NUCRO-TECHNICS and the sponsor prior to testing.

For further information about these services, to receive a quotation, or to schedule a test, please contact NUCRO-TECHNICS.