Martkbeobachtung

Die Klinische Bewertung muss pro-aktiv mit Daten aus der Marktbeobachtung gefüttert werden. Unsere Leistungen zielen darauf ab, den Prozess der Marktüberwachung zu etablieren, die Aktivitäten zur Beobachtung zu unterstützen und unseren Kunden bei der Erstellung der notwendigen Berichte zu helfen.

PMS & PMCF Gap-Analysis & Planning

MDR calls for detailed PMS & PMCF activities. Our first step to help our clients is to perform a gap-analysis and have a look at the existing procedures. From there, we collaboratively develop MDR-compliant SOPs with our clients.

PMS as a Service

Market observation is a time consuming task, especially if performed pro-actively, not relying on complaints only. Our team has detective-like skills and provides you with a not-to-worry solution to cover your pro-active duties for market surveillance.

Especially in the field of Post-market clinical follow-up, we support our clients to find slim solutions to efficiently gather as much data as necessary to grow the body of clinical data evidence that is sufficient to declare conformity.

PSUR, Post Market-Surveillance Reports

Regulation (EU) 2017/745 requires that all results and updates from market observation must be summarized into reports depending on the device class. We offer a helping hand to support our clients with these time consuming tasks and provide support with the compilation of the documentation necessary. We also make sure that the reports are taken into account in the continuous update of CERs.

Summary of Safety & Clinical Performance

For class IIb implantable products and class III products, SSCPs must be written and be made publicly available via EUDAMED. While EUDAMED might not be running by 2020-05-26, the requirement to make SSCPs publicly available remains. We help you write and update the Summaries and also provide the service of making the reports available in a centralized database.