ISO 13485 Consulting

We offer individual consultations and seminars on all management topics.

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)

ISO 13485 Beratung Chemnitz

The Project Design in ISO 13485

1. Potential analysis

System and process auditing to maintain standard-compliant QM systems

2. Documentation

Development of a plan of action

3. Implementation

Certification-ready QM systems, efficiency improvement of QM tools for medical devices, problem-solving mechanisms and internal process flows

4. Effectiveness test

Further development of competences, awareness raising and methods

5. Conformity

Ensure performance at a consistent level through targeted support

ISO 13485 Consulting


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