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eGAM Medical quality
                  Software for ISO 13485 Medical devices quality
                  management systems




                   simply perfect

www.egambpm.com
eGAM Medical quality
Software for ISO 13485 Medical devices quality management systems




                                      “
eGAM Medical quality is a high
performance software solution
                                      Meets the ISO 13485 management system objectives
designed to quality
                                      Performs 100% automated work processes
management systems,
according to ISO 13485                Eliminates 100% paper documentation and bureaucracy

standard,
standard which increases              Delegates tasks, monitors staff and motivates people
efficiency and simplifies             Eliminates nonconformities due to misunderstandings
operation by drastically reducing     Manages real-time certification and audit requirements
staff time, bureaucracy and           Controls costs of the management system
operating costs.                      Allows integration with daily tasks and IT tools




 www.egambpm.com                                                                             2
eGAM Medical quality
Software for ISO 13485 Medical devices quality management systems



• eGAM Medical quality Software            • This international standard
  allows implantation, maintenance           specifies requirements for a quality
  and certification of a management          management system where an
  system in accordance with ISO              organization needs to demonstrate
                Standard.
  13485:2003 Standard                        its ability to provide medical
                                             devices and related services that
                                             consistently meet customer
                                             requirements and regulatory
                                             requirements applicable to medical
                                             devices and related services.




 www.egambpm.com                                                              3
eGAM Medical quality
Software for ISO 13485 Medical devices quality management systems


•     Modular:
      Modular client implements modules or       •   Secure:
                                                     Secure works under Microsoft Windows ©
      processes that need.                           secure server hosting.

•     Integrated:
      Integrated with other ISO management       •   BPMS:
                                                     BPMS technology platform built on a
      systems (environment, safety…).                Business Process Management System.

•     Multi-user
      Multi-user: allows collaborative work of   •   Updates:
                                                     Updates automatically upgrading of new
      multiple users simultaneously.                 versions.

•     Multi-language
      Multi-language: works with multiple        •   Communication: integrates e-mail through
                                                     Communication
      languages simultaneously.                      Microsoft Outlook ©.

•     Multi-centric
      Multi-centric: works simultaneously in     •   Scalable:
                                                     Scalable to manage any business process
      different production plants or sites.          (projects, clients, after-sales…).

•     SaaS:
      SaaS works anywhere by internet web        •   Compatible:
                                                     Compatible with any client IT software
      (cloud computing software).                    solution (ERP, BPM, CRM …).




    www.egambpm.com                                                                           4
Please, ask for more information
•      eGAM | Software for Management System Standards
        E-mail: info@egambpm.com
        Web: www.egambpm.com
        Tel. (+34) 966 552 569
        C/. Rafael Pascual, 6
        03440 Ibi | Alicante | Spain | Europe




                                                                                  “
    eGAM is a technology platform built on BPMS (Business Process
    Management Systems) designed for companies and organizations
                                                                                      eGAM Software let me do my
    using Standards and Management Systems.                                           job, regardless of
    eGAM is a software developed by the Spanish company QMS, comprised of             bureaucratic issues that
    a team of engineers and computer professionals with large experience in
    business organization, in particular on the optimization processes to avoid       consume my day to day time
    bureaucracy and create value.



    www.egambpm.com                                                                                                5

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Software for ISO 13485 Medical devices quality management systems eGAM

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  • 2. eGAM Medical quality Software for ISO 13485 Medical devices quality management systems “ eGAM Medical quality is a high performance software solution Meets the ISO 13485 management system objectives designed to quality Performs 100% automated work processes management systems, according to ISO 13485 Eliminates 100% paper documentation and bureaucracy standard, standard which increases Delegates tasks, monitors staff and motivates people efficiency and simplifies Eliminates nonconformities due to misunderstandings operation by drastically reducing Manages real-time certification and audit requirements staff time, bureaucracy and Controls costs of the management system operating costs. Allows integration with daily tasks and IT tools www.egambpm.com 2
  • 3. eGAM Medical quality Software for ISO 13485 Medical devices quality management systems • eGAM Medical quality Software • This international standard allows implantation, maintenance specifies requirements for a quality and certification of a management management system where an system in accordance with ISO organization needs to demonstrate Standard. 13485:2003 Standard its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. www.egambpm.com 3
  • 4. eGAM Medical quality Software for ISO 13485 Medical devices quality management systems • Modular: Modular client implements modules or • Secure: Secure works under Microsoft Windows © processes that need. secure server hosting. • Integrated: Integrated with other ISO management • BPMS: BPMS technology platform built on a systems (environment, safety…). Business Process Management System. • Multi-user Multi-user: allows collaborative work of • Updates: Updates automatically upgrading of new multiple users simultaneously. versions. • Multi-language Multi-language: works with multiple • Communication: integrates e-mail through Communication languages simultaneously. Microsoft Outlook ©. • Multi-centric Multi-centric: works simultaneously in • Scalable: Scalable to manage any business process different production plants or sites. (projects, clients, after-sales…). • SaaS: SaaS works anywhere by internet web • Compatible: Compatible with any client IT software (cloud computing software). solution (ERP, BPM, CRM …). www.egambpm.com 4
  • 5. Please, ask for more information • eGAM | Software for Management System Standards E-mail: info@egambpm.com Web: www.egambpm.com Tel. (+34) 966 552 569 C/. Rafael Pascual, 6 03440 Ibi | Alicante | Spain | Europe “ eGAM is a technology platform built on BPMS (Business Process Management Systems) designed for companies and organizations eGAM Software let me do my using Standards and Management Systems. job, regardless of eGAM is a software developed by the Spanish company QMS, comprised of bureaucratic issues that a team of engineers and computer professionals with large experience in business organization, in particular on the optimization processes to avoid consume my day to day time bureaucracy and create value. www.egambpm.com 5