The Summary of Safety and Clinical Performance (SSCP) of a Class III medical device and/or implantable device is intended to provide direct information to the professional user and the patient concerned. Unlike other documents in the benefit-risk analysis of medical devices, it is therefore made available to the interested public upon request.
The Summary of Safety and Clinical Performance contains a section intended for professionals and one that is written in a way that is understandable for non-professionals. In addition to the information on indication, contraindication, warnings/risks and the exact identity of the medical device, also given in the instructions for use, the summary also describes the product history, standards applied, the treatment context including alternatives and a summary of the clinical evaluation.
The Summary of Safety and Clinical Performance essentially represents an extended instruction manual or a brief clinical evaluation.
We extract and formulate the Summary of Safety and Clinical Performance for professionals and non-professionals from the relevant parts of your instructions for use or your clinical evaluation.
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