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Quality management systems

Comprehensive support for the creation and maintenance of a Quality Management System that meets regulatory requirements and is concretely embedded in the context of your company’s reality.

Industries
Preparazione della documentazione tecnica

Preparation of QMS documentation

Gap Analysis della documentazione tecnica

Gap Analysis of the QMS from Directive to Regulation

ISO13485

Gap Analysis of the QMS against ISO13485 requirements

Consulenza per distributori e importatori di dispositivi medici e IVD

Consulting for distributors and importers of medical devices and IVDs

Validazione processi

Process Validation

Audit interno

Internal audit

Audit MDSAP

MDSAP audit

Audit a fornitori

Supplier audits

Preparazione e affiancamento per audit di certificazione

Expert Preparation and Coaching for Certification Audits

Helpdesk regolatorio

QMS helpdesk

Formazione

QMS training

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