Medical Devices Qualifications

ToxStrategies is a multidisciplinary scientific consulting firm that strives to develop innovative solutions to address the scientific, technical, and regulatory challenges confronting our clients. We have a reputation for applying sound science in all that we do, for leading-edge thinking, and for tailoring our approach to meet the specific needs of our clients, whether a rapid response or a comprehensive analysis is needed.

In medical device and combination product development, it is necessary to characterize the biological safety of the device and its components. ToxStrategies’ scientists, including board-certified toxicologists, can assist with biological evaluations tailored for the type of device and based on the intended contact with patients.

Selected examples of our experience include:

  • Support with medical device characterization by nature of body contact and duration of contact, in accordance with ISO 10993-1 (i.e., IV bag, suture, implant, wearable, etc.)
  • Toxicology study design, study monitoring, and regulatory document preparation for drug/device combinations
  • Design, outsourcing, and execution of biocompatibility studies by contract research organizations
  • Study monitoring of biocompatibility studies (including site visits and technical evaluations of contract research organizations, as necessary)
  • Data analysis and interpretation of biocompatibility results, considering factors relative to the medical device
  • Toxicological risk assessments for extractables and leachables following chemical characterization and considering expected patient exposure to the device in accordance with ISO 10993-18
  • Establishing allowable limits using specific reference doses from available literature (i.e., NOAEL or LOAEL from toxicity studies), regulated uses and limits (i.e., EPA reference dose, FDA permissible daily exposure, ATSDR minimal risk levels), and cohorts of concern (ISO/TS 21726) using uncertainty factors in accordance with ISO 10993-17
  • In silico evaluation for Cramer classification or alerting structures
  • Determining plausibility and writing study waiver justifications
  • Performing gap analysis to ensure compliance with current standards