Prozess der klinischen Bewertung

Klinische Bewertung ist ein Prozess und muss als Teil des Qualitätsmanagementsystems in einer Verfahrensbeschreibung dokumentiert werden.

SOP development

Clinical evaluation is a process and processes need to be described as part of the quality management system. We help you design your clinical evaluation process in accordance with MEDDEV 2.7/1 revision 2 and Regulation (EU) 2017/745. We also take care that your process ties in with product development, risk management, post market-surveillance and other related processes of your Quality System.

SOP review & update

Your existing SOPs for Clinical Evaluation may need an update to the new requirements of MDR and MEDDEV. We make sure that your processes are aligned and enable you to efficiently collect pre-clinical and clinical data for clinical evaluation.