At DeSia, we support you in preparing Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Clinical Performance (SSP) documents in line with MDR and IVDR requirements. These summaries are essential for ensuring transparency and clearly communicating the safety and performance of your medical or in vitro diagnostic device to healthcare professionals and patients.
What We Offer
- Preparation of structured SSCPs and SSPs with up-to-date clinical or clinical performance evidence
- Use of source documents such as clinical evaluation, scientific validity, analytical and clinical performance, risk management, PMS, PMCF, and PMPF reports
- Clear and compliant presentation of information tailored to both professionals and patients
- Regular updates based on findings from PMCF, PMPF, and Periodic Safety Update Reports (PSURs)
We ensure your summary documents remain accurate, relevant, and fully aligned with the latest regulatory expectations.
Do you need support with your SSCP or SSP? Book your complimentary initial consultation.