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E&E Medicals and Consulting

Horário de abertura

  • Domingo

    Dia de folga

  • Segunda-feira

    09:00 - 18:00

  • Terça-feira

    09:00 - 18:00

  • Quarta-feira

    09:00 - 18:00

  • Quinta-feira

    09:00 - 18:00

  • Sexta-feira

    09:00 - 18:00

  • Sábado

    Dia de folga

Sobre a empresa

E & E Medicals and consulting has well-established partners in the EU, Asia, and USA. Listed below are some of the services we offer:

FDA

RegistrationApplication Submissions(510k)US Agent for Foreign EstablishmentsFDA 483 Observations/Warning Letter/Recalls and Remediation

ISO

ISO 13485 Quality System RegistrationISO 14971 Device Risk ManagementISO 9001 Quality Management System

LICENSING & COMPLIANCE

Canada License ApplicationsPostmarket CompliancePre-IDE Process

REGISTRATION / MARK APPROVAL

CCC Mark ApprovalCE Mark ApprovalOther Countries

QUALITY ASSURANCE

AuditsQuality System RegulationRegulatory StrategyQuality Management System Implementation

SCHEDULE A MEETING OR CONFERENCE CALL WITH OUR CONSULTANTS

Nossa equipe

E & E MEDICALS AND CONSULTING

Top services

Imagem do serviço

SCHEDULE A MEETING/CALL WITH OUR CONSULTANTS

90 min

One - Time Preliminary Consultation Fee One and a half hours of preliminary consultation focuses on introducing the goals and objectives of your company.  Prospective clients will focus on general and specific issues regarding all forms of

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