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REGULATORY AFFAIRS

We turn the burden imposed by medical device regulations into a meaningful regulatory strategy delivering bottom line value.

Clariscience supports customers through the entire medical devices regulatory lifecycle, providing a full range of services, including the development of a regulatory strategy based on customers market access plans, the production of all necessary documents and their subsequent submission.

We turn the burden imposed by medical device regulations into a meaningful regulatory strategy delivering bottom line value.

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For the medical device industry

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AFFARI REGOLATORI
CONSULENZA
TRANSIZIONE DA MDD A MDR

REGULATORY MEDICAL WRITING

Preparation of Clinical Evaluation Plans (CEP) and drafting of Clinical Evaluation Reports (CER).

CREAZIONE CONTENUTI

NOTIFIED BODY SELECTION

Selecting the Notified Body best fitting your medical device and your organizational culture and structure.

CLASSIFICAZIONE DEI DISPOSITIVI MEDICI

MEDICAL DEVICE CLASSIFICATION

Is your product a medical device? In which risk class does it fall? Assessment, classification and costing implications.

SISTEMA DI REGISTRAZIONE DEI DATI

POST-MARKET SURVEILANCE

Supporting the PMS activity and assistance in case of incident involving your device.

STRATEGIA DI COMUNICAZIONE
HELPDESK SGQ

PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE

Service delivered in outsourcing for SMEs on the basis of the provision of the MDR.