Dysfunction refers to the inability of a medical device under investigation to perform its intended functions as prescribed within the provided instructions or outlined in the clinical investigation plan. This failure to operate as anticipated can arise from a variety of factors, potentially encompassing design flaws, operational errors, or unforeseen circumstances that hinder the device’s proper functionality during its utilization for medical purposes.
Signal Management Process
Contact our experts today
Composed of proven experts from the pharmaceutical industry, our team is ready to answer to your needs in any
area of product development, commercialisation and early access programs, and life cycle management