SSCP: The key to medical device safety and EU compliance
The Summary of Safety and Clinical Performance (SSCP) plays a vital role in the realm of medical devices, as mandated by the European Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). This document serves as a concise yet comprehensive overview of a medical device's safety and performance characteristics.
Writing a SSCP for you
Our medical writing service offers comprehensive SSCP preparation for both patients and healthcare professionals, crafting tailored summaries of performance and safety data for your devices. We present this data in a clear and compliant manner, meeting the requirements outlined in MDR 2017/745.
We can help
We will be happy to prepare the SSCP for you - be it for patients or healthcare professionals.
Compliance
Experience in the implementation of the requirements of MDR 2017/745 and MDCG 2019-09 rev. 1.
Simple language
Writing the SSCP for patients in an easy and understandable language.
Aligned
Alignment with other relevant parts of the Technical Documentation.
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Molecule classesWe can support you with our expertise across the full spectrum of drug development: from small to large molecules, biologics to oligonucleotides and more.
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Development stagesTODO
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Species selectionTODO
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Technologiese.g. silencing novel approaches?
