Regulatory Due Diligence
The main objective of this module is to facilitate an investment decision by performing US FDA and Health Canada regulatory due diligence on the product and clinical documentation, identify any gaps or flag any concerns, and recommend mitigation strategies as applicable.
Module deliverables:
Examine the current product claims, intended use, indications for use, instructions for use, user manuals, and labels from a US FDA and Health Canada regulatory perspective and perform due diligence on the information
Provide our professional opinion on the current regulatory pathway complete with validations, red flags, and recommended steps
Advise on regulatory strategies to accomplish targeted US FDA and Health Canada medical device classification and licensing
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