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We carefully review all support requests. IIS applications undergo extensive assessment by a cross-functional team consisting of medical, clinical, and other technical staff.

The following criteria are important factors for assessing IIS proposals:
  • Safety and welfare of the subjects
  • Originality or novelty of research
  • Scientific and statistical soundness
  • Impact on clinical and commercial strategies
  • Impact on intellectual property portfolio
  • Consideration of good clinical practices (GCP)
  • Consistency with governmental and corporate health care compliance directives
The company generally does not provide support for studies:
  • That involve investigational/pre-cleared/pre-market devices
  • In which the primary study objective is intended to support a registration effort, labeling changes, or other regulatory action

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