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QMS implementation and maintenance

Preparation of QMS documentation

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Preparation of QMS documentation

We offer a highly customisable consulting service for the preparation and/or maintenance of the company’s quality system in accordance with the requirements of the Medical Device Regulation and the IVD Regulation and/or in accordance with the requirements of ISO 13485.

Working closely with your team, we’ll craft customized procedures and data recording systems that not only meet mandatory requirements but also seamlessly integrate with your company’s operations. Our goal is to ensure your Quality Management System (QMS) is not just effective but embraced across your entire organization.

Already have a QMS in place? We will work alongside your personnel to optimize it and we will collaborate to identify and streamline processes, eliminating unnecessary redundancies and complexities to enhance your operational efficiency.

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