A core competency of confinis lies in the construction of quality management systems according to EN ISO 13485:2016 (incl. consideration of EU MDR requirements), and 21 CFR Part 820, respectively, for the US market.
A quality management system consists of procedures that are implemented in clearly structured SOPs (Standard Operating Procedures) and associated templates (checklists, forms, etc.).
The key component to keep these processes organized is the quality manual. It forms the basis for a successful quality management system certification according to EN ISO 13485:2016. A certified management system not only helps obtain a successful product certification but also guarantees increased transparency of the various business processes and thereby significantly reduces error rates.
We conduct the necessary processes according to the relevant standards and tailored to your company’s activities. In addition, we define the process ownership and set the interface for other processes. Defining the KPIs (Key Performance Indicators) helps monitor the effectiveness of the implemented processes.