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QMS implementation and maintenance

Gap Analysis of the QMS from Directive to Regulation

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Gap Analysis of the QMS from Directive to Regulation

Our Gap Analysis service helps companies in the medical device and IVD sectors determine whether their Quality Management System (QMS) documentation meets the requirements of the new EU Regulations 2017/745 and 746. This service evaluates your existing documentation, originally prepared to comply with the Medical Devices Directive or the IVD Directive, to ensure it also complies with the new regulations. If there are gaps, we identify the necessary adjustments to bring your documentation into full compliance.

This service is essential for any organization with a QMS, ensuring your compliance with the latest legal requirements in the medical device and IVD industries.

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