Medical & Regulatory

CE Marking, MDR and IVDR

Comprehensive regulatory support for the commercialization of medical devices and in vitro diagnostic medical devices (IVDs) in Italy and across the European Union.

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ISO 13485

TentaConsult Italia supports medical device manufacturers and IVD companies in the development and implementation of Quality Management Systems (QMS) compliant with MDR, IVDR, and applicable regulatory requirements for commercialization in Italy and across the European Union.

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Global Market Access

TentaConsult Italia supports manufacturers, importers, and distributors of medical devices, IVDs, cosmetics, and biocidal products in managing the regulatory approvals, registrations, and compliance activities required to access international and non-EU markets.

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Ministry Registrations and EUDAMED

TentaConsult Italia supports manufacturers, importers, and distributors in managing national regulatory registrations and EUDAMED activities for medical devices and in vitro diagnostic medical devices (IVDs), providing technical and regulatory support to ensure compliance with MDR and IVDR requirements in Italy and across the European Union.

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Biological Evaluation

We support medical device manufacturers and biomedical companies in managing the biological evaluation of medical devices in compliance with Regulation (EU) 2017/745 (MDR) and the ISO 10993 series.

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Clinical Evaluation

TentaConsult Italia supports medical device manufacturers, biomedical companies, and healthcare organizations in the preparation, maintenance, and management of clinical evaluation activities in compliance with Regulation (EU) 2017/745 (MDR).

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Software validation

TentaConsult Italia supports medical device, biomedical, and healthcare companies in the validation of product and process software in accordance with ISO 13485, IEC 62304, and a risk-based approach.

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