Medical devices

Clinical investigation

One of the key to CE marking of medical devices is the validation of clinical safety and performance. With our team of doctors and biologists, we provide a full range of services from the design of clinical investigations, through licensing to the preparation of a clinical investigation report.

Standard, legislation, guidance

Description

MDR XV. Chapter

II. 3.

Preparation of the Clinical Investigation Plan; data collection, literature search

MDR XV. Chapter

II. 1-2.

Preparation of the documentation regarding the application for clinical investigation

MDR Art. 70

Prepare the Clinical Investigation authorization (submitting the application, communication with the authority)

MDR Art. 72

 

Conduct of the Clinical Investigation, including:

·        Article 77. Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination,

·        Article 80. Recording and reporting of adverse events that occur during clinical investigations.

MDR Art. 87

Supporting the reporting of serious incidents and field safety corrective actions

MDR XV. Chapter

III. 4-6.

Follow the Clinical Investigation (monitoring, data management, project management)

MDR XV. Chapter

III. 7.

Prepare a clinical investigation report

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