Gap Analysis

Maximizing the use of historical data to refine testing programs,  complying with ISO 10993 while avoiding unnecessary new testing.

Assessing the gap between the known and unknown.

Life science product developers want to ensure that their historic testing results are still compliant with contemporary testing standards. Manufacturers may also want to verify that their testing program is complete for the classification of their device. Gap analysis helps them maximize the use of historical data and refine their current testing program to be fully compliant with ISO 10993 while avoiding unnecessary new testing.

Regulatory authorities want assurance that there has not been any change in:

  • the source or in the specification of the materials used in the manufacture of the product in the formulation, processing, primary packaging or sterilization of the product
  • the manufacturer’s instructions or expectations concerning storage, such as changes in shelf life and/or transport
  • the intended use of the product
  • evidence that the product may produce adverse effects when used in humans

ToxSmart can confirm whether these situations have occurred through:

  • Investigating supply-chain changes
  • Obtaining relevant data from raw material suppliers and fabricators
  • Summarizing test data while assuring complete confidentiality

If any of these situations have occurred the product needs to be re-evaluated; ToxSmart can determine if those changes are significant enough as to warrant re-evaluation.

Regulatory Guidance

  • ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process
  • ISO 10993-17: Biological Evaluation of Medical Devices – Part 17: Establishment of Allowable Limits for Leachable Substances
  • ICH Q3D. 2015: Elemental Impurities: Guidance for Industry, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER)
  • ICH M7. 2015: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, Guidance for Industry
  • ISO 14971, 2007: International Standard. Medical Devices- Application of Risk Management to Medical Devices. Second Edition. Reference Number ISO 14791:2007(E).
  • ISO 18562: Bioco