Quality Management

ISO 13485

Medical Production

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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 Process - 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. Efficacy Testing

Further development of competences, awareness raising and methods

5. CIP (Continuous Improvement Process)

Ensure performance at a consistent level through targeted support

Request ISO 13485 consultation

Quality Management

ISO 13485

Make your medical device safe and effective according to the latest standard ISO 13485

The Project Process - ISO 13485

Request ISO 13485 consultation

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