QUALITY MANAGEMENT SYSTEMS

We implement ISO 13485 or support yor company upgrading from ISO 9001.

We advise on, develop and implement Quality Management Systems for manufacturers and distributors of medical devices, under ISO 9001 and ISO 13485.

Clariscience assists customers in devising compliance strategies in a number of ways, including pre- and post-market compliance activities, quality system implementation, risk management, and medical device product design control support.

Iso compliance for the medical device industry.

CONSULENZA QMS

QMS CONSULTING

Consultancy for the preparation and the maintenance of the quality system according to ISO 13485.

SISTEMA DI REGISTRAZIONE DEI DATI

DATA RECORDING SYSTEMS

Preparation of an efficient documentation structure to collect the objective evidences required by the applicable standards and regulations.

INTERNAL AUDIT

Qualified Lead Auditors conducting pre-inspection audits to assess the conformity of the QMS to internal procedures and relevant...

GAP ANALYIS OF QMS FROM MDD TO MDR

Making sure your organization gets a clear view on the actions needed to achieve full compliance with MDR of its QMS.

HELPDESK SGQ

QMS HELPDESK

Day-to-day helpdesk in support of your internal staff providing fast and reliable answers.

FORMAZIONE

TRAINING

Preparation of an efficient documentation structure to collect the objective evidences required by the applicable standards and regulations.

STRATEGIA DI COMUNICAZIONE

Uniamo competenze marketing e scientifiche per disegnare strategie di comunicazione in grado di valorizzare le caratteristiche competitive di marchi, prodotti e servizi dei nostri clienti.

CREAZIONE DI CONTENUTI

Questo è il territorio in cui la scienza incontra la comunicazione e dove il nostro team di medical writer trasforma dati grezzi e argomenti complessi in una gamma di diversi strumenti di comunicazione: web copywriting, white paper, contenuti editoriali, e-book.

INTERNAL AUDIT

Qualified Lead Auditors conducting pre-inspection audits to assess the conformity of the QMS to internal procedures and relevant standards and directives. SECOND PARTY AUDIT Audits to suppliers of manufacturers/producers of medical devices to assess the level of compliance with ISO 13485.