Bericht zur Klinischen Bewertung

Wir unterstützen unsere Kunden in jeder Phase des Prozesses der Klinischen Bewertung.
  • Stage 0: plan the product specific clinical evaluation according to the requirements of MEDDEV 2.7/1 revision 4 and Regulation (EU) 2017/745
  • Stage 1: identify pertinent clinical and non-clinical data from the relevant sources
  • Stage 2: appraise the identified clinical data from clinical investigations as well as scientific literature and other sources
  • Stage 3: analyse the relevant data sets and build the body of evidence based on sufficient clinical data
  • Stage 4: compile the clinical evaluation report, summarizing the results of clinical evaluation in support of evidence of the general safety and performance requirements

Klinische Bewertung ist ein fortwährender Prozess. Wir bieten daher auch die kontinuierliche Aktualisierung der Berichte zur Klinischen Bewertung mit neuen klinische Daten an.

Zusätzliche Leistungen

 

CER-Gap Analysis

In order to get an overview of the status of the current CER, we offer to review your existing documentation and provide a report that allows you to plan your activities. Due to the new requirements of Regulation (EU) 2017/745 and the recommendations of MEDDEV 2.7/1 revision 4, the gap analysis will help you identify uncertainties in the existing CER and plan ahead to take the necessary steps to MDR compliance.

Expert reviews

Clinical Evaluation must be performed by a team of qualified authors and evaluators. As many manufacturers lack the inhouse expertise to comply with the requirements, we offer our expert reviews of your clinical evaluations and complement your teams. Depending on the needs, we can either focus on the regulatory compliance review or on the medical review or both.

Clinical Evaluation Update Service

Depending on the medical device class and the device specifics (e.g. established device vs. high-tech innovation) the updates of the CER have to be performed regularly. We support our clients with regular updates without the need to think about it.