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Clariscience
 
  • HOME
  • SERVICES
  • ABOUT US
  • NEWS&STORIES
  • CONTACTS
  • EN
  • IT
  • HOME
  • SERVICES
  • ABOUT US
  • NEWS&STORIES
  • CONTACTS
  • EN
  • IT

CAMPAIGNS

    Clariscience
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    CLARISCIENCE SRL

    Largo Europa 1
    35137 – Padova (IT)

    REGISTERED OFFICE

    Via del Vecchio Politecnico, 9
    20121 – Milano (IT) 

    CONTACTS

    T +39 049 7443622
    @ info@clariscience.com

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    Clariscience
    • HOME
    • SERVICES
      • Regulatory affairs
        • Technical documentation of medical devices and IVDs
          • Technical documentation Gap Analysis
          • Classification of medical devices and IVDs
          • Preparation of the technical documentation
          • Labelling compliance analysis
          • Risk analysis activities
          • Supporting PMS activities
        • Biological Evaluation Plan e Report
        • Clinical evaluations (MD), PMCF and SSCP
        • Import and access to foreign markets
          • Assistance for the import of for Medical Devices and IVDs
          • Support for access to non-EU markets
        • Regulatory support
          • Medical Device and IVD advertising authorisation
          • Assistance in interacting with the Notified Body
          • Person Responsible for Regulatory Compliance
          • Eudamed and Italian Databases Registration
          • Regulatory Due Diligence
          • Regulatory helpdesk
        • Performance evaluations (IVD)
        • Usability assessments
        • Regulatory training
      • Quality management systems
        • QMS implementation and maintenance
          • Preparation of QMS documentation
          • Gap Analysis of the QMS from Directive to Regulation
          • Gap Analysis of the QMS against ISO13485 requirements
          • Consulting for distributors and importers of medical devices and IVDs
          • Process Validation
        • Auditing
          • Internal audit
          • MDSAP audit
          • Supplier audits
          • Expert Preparation and Coaching for Certification Audits
        • QMS helpdesk
        • QMS training
      • Medical writing and scientific communication
        • Medical Writing
        • Clinical writing
        • Data analysis
        • Texts and content
        • Visual communication
        • The handbook for the pharmaceutical sales representative
        • Advisory boards
        • Presenting data at scientific events
    • ABOUT US
      • WORK WITH US
      • CORPORATE
    • NEWS&STORIES
    • CONTACTS
    • EN
    • IT

    Desideri avere maggiori informazioni sui nostri servizi?

    CONTATTACI
    Clariscience

    SERVICES

    Regulatory affairs

    • Technical documentation of medical devices and IVDs
    • Biological Evaluation Plan e Report
    • Clinical evaluations (MD), PMCF and SSCP
    • Import and access to foreign markets
    • Regulatory support
    • Performance evaluations (IVD)
    • Usability assessments
    • Regulatory training
    Technical documentation Gap Analysis Technical documentation Gap Analysis
    Classification of medical devices and IVDs Classification of medical devices and IVDs
    Preparation of the technical documentation Preparation of the technical documentation
    Labelling compliance analysis Labelling compliance analysis
    Risk analysis activities Risk analysis activities
    Supporting PMS activities Supporting PMS activities
    Assistance for the import of for Medical Devices and IVDs Assistance for the import of for Medical Devices and IVDs
    Support for access to non-EU markets Support for access to non-EU markets
    Medical Device and IVD advertising authorisation Medical Device and IVD advertising authorisation
    Assistance in interacting with the Notified Body Assistance in interacting with the Notified Body
    Person Responsible for Regulatory Compliance Person Responsible for Regulatory Compliance
    Eudamed and Italian Databases Registration Eudamed and Italian Databases Registration
    Regulatory Due Diligence Regulatory Due Diligence
    Regulatory helpdesk Regulatory helpdesk

    Quality management systems

    • QMS implementation and maintenance
    • Auditing
    • QMS helpdesk
    • QMS training
    Preparation of QMS documentation Preparation of QMS documentation
    Gap Analysis of the QMS from Directive to Regulation Gap Analysis of the QMS from Directive to Regulation
    Gap Analysis of the QMS against ISO13485 requirements Gap Analysis of the QMS against ISO13485 requirements
    Consulting for distributors and importers of medical devices and IVDs Consulting for distributors and importers of medical devices and IVDs
    Process Validation Process Validation
    Internal audit Internal audit
    MDSAP audit MDSAP audit
    Supplier audits Supplier audits
    Expert Preparation and Coaching for Certification Audits Expert Preparation and Coaching for Certification Audits

    Medical writing and scientific communication

    • Medical Writing
    • Clinical writing
    • Data analysis
    • Texts and content
    • Visual communication
    • The handbook for the pharmaceutical sales representative
    • Advisory boards
    • Presenting data at scientific events

    Would you like more information about our services.

    CONTACT US
    Clariscience
    • HOME
    • SERVICES
      • Regulatory affairs
        • Technical documentation of medical devices and IVDs
          • Technical documentation Gap Analysis
          • Classification of medical devices and IVDs
          • Preparation of the technical documentation
          • Labelling compliance analysis
          • Risk analysis activities
          • Supporting PMS activities
        • Biological Evaluation Plan e Report
        • Clinical evaluations (MD), PMCF and SSCP
        • Import and access to foreign markets
          • Assistance for the import of for Medical Devices and IVDs
          • Support for access to non-EU markets
        • Regulatory support
          • Medical Device and IVD advertising authorisation
          • Assistance in interacting with the Notified Body
          • Person Responsible for Regulatory Compliance
          • Eudamed and Italian Databases Registration
          • Regulatory Due Diligence
          • Regulatory helpdesk
        • Performance evaluations (IVD)
        • Usability assessments
        • Regulatory training
      • Quality management systems
        • QMS implementation and maintenance
          • Preparation of QMS documentation
          • Gap Analysis of the QMS from Directive to Regulation
          • Gap Analysis of the QMS against ISO13485 requirements
          • Consulting for distributors and importers of medical devices and IVDs
          • Process Validation
        • Auditing
          • Internal audit
          • MDSAP audit
          • Supplier audits
          • Expert Preparation and Coaching for Certification Audits
        • QMS helpdesk
        • QMS training
      • Medical writing and scientific communication
        • Medical Writing
        • Clinical writing
        • Data analysis
        • Texts and content
        • Visual communication
        • The handbook for the pharmaceutical sales representative
        • Advisory boards
        • Presenting data at scientific events
    • ABOUT US
      • WORK WITH US
      • CORPORATE
    • NEWS&STORIES
    • CONTACTS
    • EN
    • IT

    Would you like more information about our services?

    CONTACT US
    Clariscience

    ABOUT US

    Corporate

    Learn about the values that underpin our company, the ecosystem within which the people who work with us operate, the approach we take to customer relations, and the charity initiatives we have selected and supported over the years.

    Work with us

    Work with us

    Find out about any vacancies, send your spontaneous application and find out about the job profiles of those who already work with us.

    Programma segnalatori

    Referral program

    If you work in the life science sector, there is a new opportunity waiting for you. By participating in the Clariscience Referral Programme you can economically capitalise on your expertise and your network of contacts.

    Would you like more information about our services?

    CONTACT US