Modernisation of the quality management system:
The main objective was to modernise the existing quality management system (QMS). A comprehensive analysis was carried out to identify weaknesses and improve inefficient processes.
The revised QMS complied with the requirements of EN ISO 13485 to ensure that the company maintains the highest quality standards.Recertification according to EN ISO 13485:
During the EN ISO 13485 recertification process, the company was supported by our experts. All necessary steps were taken to fulfil the requirements and achieve successful recertification.
Recertification according to EN ISO 13485:
During the recertification process according to EN ISO 13485, the company was supported by our experts. All necessary steps were taken to fulfil the requirements and achieve successful recertification.
Development of in-house QM & Regulatory Affairs capacities:
Our experts led the development of in-house Quality Management (QM) and Regulatory Affairs (RA) capabilities. Training and guidance was provided to ensure the team had the necessary knowledge and skills to meet future challenges.
Creation of technical documentation for IVD devices:
Our specialists assisted in the creation of technical documentation for in vitro diagnostic (IVD) devices. This included the creation of high-quality documents that complied with regulatory requirements and standards.
Upon completion of the project, the company had a modernised quality management system that met the requirements of EN ISO 13485 and positioned the company at a high level of quality. Internal capacities in the area of QM & Regulatory Affairs were strengthened and well-documented technical documentation for IVD devices was created.
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