Medical Device Testing Overview

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: Toxicology, Genetic Toxicology, Microbiology, and Chemistry.  From a regulatory perspective, Phase I, Phase III, and Phase IV are covered by Good Manufacturing Practice Regulations (GMP) while the Biological Evaluation of Medical Device (or biocompatibility studies) are covered by the ISO 10993 regulations and run to the GLP standard.

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:

Testing Phases
Service Details
Phase I: Raw Material Characterization and Screening
  • Physicochemical tests
  • Infrared Identification
Phase II: Material Biocompatibility (Per FDA / AAMI and ISO 10993)
  • Cytotoxicity
  • Sensitization
  • Irritation or Intracutaneous Reactivity
  • Acute Systemic Toxicity
  • Material-Mediated Pyrogenicity
  • Subacute / Subchronic Toxicology
  • Genotoxicity Testing
  • Implantation Studies
  • Hemocompatibility Studies
  • Chronic Toxicity
  • Carcinogenicity
Phase III: Product & Process Validation
  • Microbial Evaluation
  • Sterilization Cycle Validation
  • LAL / Particulate Analysis
Phase IV: Routine Testing
  • Finished Product Qualification
  • Release Testing
  • Audits

There are many different methods of analysis that can be utilized to go through all of the testing phases. 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.

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