QFI’s Biological Safety Programme evaluates composition of raw materials, intermediate and finished products ranging from permanent implants, intravascular catheters, permanent cardiac implants, left ventricular assist devices (PMA), plus lesser devices to determine whether anticipated intolerance by the body can be predicted. Success will depend on availability, depth and currency of prevailing, promulgated information, including reliance on reference (State-of-the-Art) devices such as 510(k) premarket authorisation:

  • Description of product in technical detail sufficient and as relevant to understand:
  • Materials of construction (including ancillary materials, particularly, surface treatments, adhesives, etc)
  • Mode of contact with the body (eg, percutaneous, circulating blood, central circulation, tissue, organ etc)
  • Duration of contact intended by the Manufacturer (including any discontinuous use)
  • Relevant information including reference device that may be relied whether made by the Manufacturer or competitor
  • Factors that could lead or accelerate degradation in vivo (eg, radiation, including ultra-violet, radio waves, plasma, elevated temperature etc); method of sterilisation
QFI conducts biological evaluation according to §3.1 and §3.2 EN ISO 10993-1 + FDA guidance, as appropriate, considering absolute and relative concentrations of known toxic materials, compounds, materials in the device and method of manufacture, etc. QFI can also audit biological safety assessment provisions applied to medical devices and device-drug combinations. QFI is able to investigate and guide remedies when excursions in the biological safety profile of products occur, including evaluation of the merits of analytical techniques and standard methods. Further, QFI can assist in correct design of test conditions, guide judicious selection and waiver of tests depending on the state-of-the-Art and constructive knowledge. QFI is adept at fundamental research of biological safety data to guide logical decisions in selecting and combining bio-materials and help to limit risk of regulatory exposure.


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