ISO 13485 Consulting
Make your medical device safe and effective according to the latest standard ISO 13485
Although the quality management system (QMS) has fundamental similarities to ISO 9001:2015, the medical production standard pursues a different goal. It is not about continuous improvement at any price. Rather, the aim is sustainable compliance with externally required and internally self-imposed standards.
We support you in the implementation, maintenance and further development of your QMS for medical devices by means of:
– Compliance with the requirements of the MDR (Medical Device Regulation), which will be generally applicable from 26.05.2021.
– Design of the CAPA process (preventive and corrective actions)
– Documentation / training / monitoring for compliance with ISO 13485
– External quality management representative (QMB)
The Project Design in ISO 13485
System and process auditing to maintain standard-compliant QM systems
Development of a plan of action
Certification-ready QM systems, efficiency improvement of QM tools for medical devices, problem-solving mechanisms and internal process flows
Further development of competences, awareness raising and methods
Ensure performance at a consistent level through targeted support