Module 14 2022

21/03/2022

Design clinical investigation

“Clinical investigations should be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the manufacturer's claims regarding the safety, performance and aspects relating to benefit- risk of devices; the clinical investigations shall include an adequate number of observations to guarantee the scientific validity of the conclusions.”

The Organisation for Professionals in Regulatory Affairs

Statistical Considerations in Medical Device Clinical Investigations

11

Set investigation objective

• QUIZ QUESTION: What is the purpose of an investigational objective? • To provide the essential focus for the investigation • To enable the design of an efficient and effective clinical investigation • To evaluate accurately the use of the device in the target condition and population • To provide the basis for labelling indications once the device is placed on the market • All of the above

The Organisation for Professionals in Regulatory Affairs

Statistical Considerations in Medical Device Clinical Investigations

12

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