• Customer Center
  • Partner Center
  • Store
  • Contact us
DEESFRITPTRU日本語 (JA)
EN
  • Products
    • By business needs
      • Overview
      • Business Process Management – BPM
      • Corporate Performance Management – CPM
      • Enterprise Asset Management – EAM
      • Enterprise Content Management – ECM
      • Enterprise Quality Management – EQM
      • Enterprise Risk Management – ERM
      • Environmental, Social and Corporate Governance Management – ESG
      • Governance, Risk and Compliance Management – GRC
      • Human Development Management – HDM
      • Innovation and Change Management – ICM
      • Enterprise Service Management – ESM
      • Product Lifecycle Management – PLM
      • Project and Portfolio Management – PPM
      • Supplier Lifecycle Management – SLM
    • By industry
      • Overview
      • Aerospace and Defense
      • Agribusiness
      • Architecture, Engineering & Construction
      • Automotive
      • Chemicals
      • Consumer Goods
      • Education
      • Energy & Utilities
      • Financial Services
      • Food & Beverage
      • Healthcare
      • High-tech
      • Medical Devices
      • Mining & Metals
      • Pharmaceuticals & Biotechnology
      • Public Sector & Associations
      • Retail
      • Transportation & Logistics
    • By regulation
      • Overview
      • AS9100
      • BPMN
      • BSC
      • CBOK
      • CMMI
      • COBIT
      • COSO
      • FDA 21 CFR Part 11
      • FDA 21 CFR Part 820
      • FSSC 22000
      • GDPR
      • IATF 16949
      • ISO 10015
      • ISO 13485
      • ISO 14000
      • ISO 15189
      • ISO 19011
      • ISO 20000
      • ISO 22000
      • ISO 22301
      • ISO 26000
      • ISO 27001
      • ISO 31000
      • ISO 37001
      • ISO 45001
      • ISO 50001
      • ISO 55000
      • ISO 9000
      • ISO/IEC 17025
      • ISO/TS 14253
      • ITIL
      • OHSAS 18000
      • PMBOK
      • Six Sigma
      • SOX
    • All products
      • Overview
      • Action Plan
      • Analytics
      • APQP-PPAP
      • Archive
      • Asset
      • Audit
      • Calibration
      • Capture
      • Competence
      • Customer
      • Document
      • FMEA
      • Form
      • Incident
      • Inspection
      • Kanban
      • Knowledge Base
      • Maintenance
      • Meeting
      • MSA
      • PDM
      • Performance
      • Portfolio
      • Problem
      • Process
      • Project
      • Protocol
      • Request
      • Requirement
      • Risk
      • SPC
      • Storeroom
      • Supply
      • Supplier
      • Survey
      • Time Control
      • Training
      • Workflow
    • SoftExpert Excellence Suite
    • SoftExpert Excellence Suite
  • Services
    • Overview
    • Training
    • Cloud Computing
    • Consulting and Implementation
    • Customization Services
    • Integration
    • Performance Optimization
    • Service Hours Pack
    • Support
    • Validation
  • Company
    • About us
    • Contact us
    • Business Partners
      • Find a Partner
      • Strategic alliances
      • Become a Partner
      • Qualification Form
    • Careers
    • Channel of Reports
    • Events
  • Customers
    • Overview
    • Success cases
    • Testimonials
    • Video Case
  • Resources
  • News
  • Blog
    • Customer Center
    • Partner Center
    • Store
    • Contact us

    Medical Devices

    Request a Live Demo
  • Download / Contact
    • Brochure / Demo
    • More Information
    • Request a Live Demo
    • The Solution
    • Benefits
    • Brochure / Demo
    • More Information
    • Request a Live Demo

    Home » Medical Devices

    The Challenge

    The medical device industry can be credited with numerous examples of improving healthcare and quality of life for patients all over the world, but they also face unprecedented pressure and understanding the regulatory and demographic environment of the industry is only part of the challenge. The real struggle for medical device companies is defining the right strategy and then efficiently executing it.

    SoftExpert offers the industry’s most advanced and comprehensive software suite for compliance and performance management that meets the stringent needs of the medical devices industry in all aspects from controlling documentation, risks to performance indicator monitoring, projects, assets, product lifecycle management and much more.

    Medical Devices Solution

    SoftExpert Excellence Suite lowers the cost of regulatory compliance and helps companies in the medical devices industry maximize success, increase productivity, reduce risk and adhere to various global regulations such as ISO 9001 and ISO 13485.

    The solution enables companies to continuously improve operations by adhering to various international regulations as well as integrating in a single platform of different management frameworks including: managing risks, maintenance, processes, assets, calibrations, product development, performance indicators, and much more.

    By offering staff with insight in their role in end-to-end activities, they become better able to recognize opportunities improvement and keep up with the dramatic shifts in the industry’s competitive global environment. Powerful support for collaboration with coworkers across organizational boundaries then enables them to play a central role in making smart improvements in the way the organization serves its clients.

    Read More
    Read More

    SoftExpert Suite simplifies and standardizes excellence and compliance management processes by providing a software platform with a central point of access to all up-to-date process documentation, key performance indicators, related documentation such as policies, templates, procedures and task related applications, as well as an online platform for registering suggestions, risks, complications and initiatives.

    • Business process modeling (BPMN)

      Business process modeling (BPMN)

    • Risk management

      Risk management

    • Applicability assessment and requirement implementation

      Applicability assessment and requirement implementation

    • Product management

      Product management

    Main Benefits

    Effective Bill of Materials (BOM) management.

    Manages non-conformities.

    Controls item documentation review.

    Empowers business users to write, manage, and modify rules to better match business needs.

    Creates multi-maps that combine individual process maps into a single map representing the overall business process.

    Edits and shares project data in real time. Task precedence inter-relationships (Work Breakdown Structure-WBS) on Gantt charts, critical path, precedence net, and milestone.

    Analyzes the progress of your projects, displaying “estimated vs. actual” and calculates trends throughout all project phases until their conclusion.

    Prevention of new nonconformities.

    Streamlines isolated tasks and action plan planning, execution and monitoring.

    Analyses risks quantitatively, qualitatively and through risk matrix.

    Monitors risk management history.

    Schedules preventive maintenance.

    Manages total maintenance via Service Order.

    Calculates cost automatically by technician, equipment, activity, service order, period, maintenance team, estimated service cost, etc.

    Brochure / Demo More Information Request a Live Demo
    Solution Overview

    Solution Overview

    (If you can't see this video, click here)

    Know some success stories

    More Resources

    Featured Resources

    Ebook

    How to overcome challenges and boost results in the medical devices industry

    Read this eBook to find out the nine pillars to help medical device companies overcome barriers to excellence.
    Learn more
    DOWNLOAD

    White Paper

    How will ISO 13485:2016 impact your relationship with suppliers?

    The importance of the "risk based approach" for the correct performance and adequate safety of medical devices.
    Learn more
    DOWNLOAD

    Ebook

    ISO 13485:2016 – What you need to know

    Read this eBook and be better prepared to conduct a smooth transition of ISO 13485 at your organization.
    Learn more
    DOWNLOAD
    More Resources

    See also

    ISO 13485
    SoftExpert Excellence Suite
    SoftExpert ERM
    SoftExpert EQM
    Por favor, preencha o formulário e fale conosco
    *Required field

    E-mail*

    Nome Completo*

    Cargo*

    Telefone*

    Empresa*

    Indústria*




    País*




    Estado*




    Necessidade de compra de uma solução*




    Mensagem

    Ao clicar no botão abaixo, você confirma que leu e aceita nossa Política de Privacidade










    Products

    • SoftExpert Excellence Suite
    • By Business needs
    • By Industry
    • By Regulation
    • All Products
    x
    Request a Software Demo:
    Invalid E-mail.

    Overview

    • Resources
    • Services
    • News
    • Store
    • Blog

    Company

    • About Us
    • Business Partners
    • Customers
    • Customer Center
    • Partner Center
    • Channel of Reports
    • Careers

    Contacts

    CSC: +55 (47) 2101 9999
    Contact us
    Facebook
    Twitter
    LinkedIn
    YouTube
    Instagram

    Newsletter

    By registering, you agree to our Privacy Policy.

    Invalid e-mail

    Softexpert Copyright © SoftExpert Software for Performance Excellence.
    All trademarks, trade names, service marks, and logos referenced herein belong to their respective companies.
    • Política de privacidade

    Online Sales

    Online Sales SOftExpert
    SoftExpert
    Online Sales

    Online Sales SOftExpert

    Hi, can we help you with more information about our solutions?

    Yes No, thank you.

    Nós usamos cookies para oferecer a melhor experiência possível em nosso site. Para saber mais, visite nossa Privacy Policy
    Ao continuar a usar este site ou ao fechar esta caixa, você concorda com o uso de cookies.

    Ok
    SoftExpert
    • Products
      • By business needs
        • Overview
        • Business Process Management – BPM
        • Corporate Performance Management – CPM
        • Enterprise Asset Management – EAM
        • Enterprise Content Management – ECM
        • Enterprise Quality Management – EQM
        • Enterprise Risk Management – ERM
        • Environmental, Social and Corporate Governance Management – ESG
        • Governance, Risk and Compliance Management – GRC
        • Human Development Management – HDM
        • Innovation and Change Management – ICM
        • Enterprise Service Management – ESM
        • Product Lifecycle Management – PLM
        • Project and Portfolio Management – PPM
        • Supplier Lifecycle Management – SLM
      • By industry
        • Overview
        • Aerospace and Defense
        • Agribusiness
        • Architecture, Engineering & Construction
        • Automotive
        • Chemicals
        • Consumer Goods
        • Education
        • Energy & Utilities
        • Financial Services
        • Food & Beverage
        • Healthcare
        • High-tech
        • Medical Devices
        • Mining & Metals
        • Pharmaceuticals & Biotechnology
        • Public Sector & Associations
        • Retail
        • Transportation & Logistics
      • By regulation
        • Overview
        • AS9100
        • BPMN
        • BSC
        • CBOK
        • CMMI
        • COBIT
        • COSO
        • FDA 21 CFR Part 11
        • FDA 21 CFR Part 820
        • FSSC 22000
        • GDPR
        • IATF 16949
        • ISO 10015
        • ISO 13485
        • ISO 14000
        • ISO 15189
        • ISO 19011
        • ISO 20000
        • ISO 22000
        • ISO 22301
        • ISO 26000
        • ISO 27001
        • ISO 31000
        • ISO 37001
        • ISO 45001
        • ISO 50001
        • ISO 55000
        • ISO 9000
        • ISO/IEC 17025
        • ISO/TS 14253
        • ITIL
        • OHSAS 18000
        • PMBOK
        • Six Sigma
        • SOX
      • All products
        • Overview
        • Action Plan
        • Analytics
        • APQP-PPAP
        • Archive
        • Asset
        • Audit
        • Calibration
        • Capture
        • Competence
        • Customer
        • Document
        • FMEA
        • Form
        • Incident
        • Inspection
        • Kanban
        • Knowledge Base
        • Maintenance
        • Meeting
        • MSA
        • PDM
        • Performance
        • Portfolio
        • Problem
        • Process
        • Project
        • Protocol
        • Request
        • Requirement
        • Risk
        • SPC
        • Storeroom
        • Supply
        • Supplier
        • Survey
        • Time Control
        • Training
        • Workflow
      • SoftExpert Excellence Suite
      • SoftExpert Excellence Suite
    • Services
      • Overview
      • Training
      • Cloud Computing
      • Consulting and Implementation
      • Customization Services
      • Integration
      • Performance Optimization
      • Service Hours Pack
      • Support
      • Validation
    • Company
      • About us
      • Contact us
      • Business Partners
        • Find a Partner
        • Strategic alliances
        • Become a Partner
        • Qualification Form
      • Careers
      • Channel of Reports
      • Events
    • Customers
      • Overview
      • Success cases
      • Testimonials
      • Video Case
    • Resources
    • News
    • Blog

      padrao

      • DE (DE)
      • EN
      • ES (ES)
      • FR (FR)
      • IT (IT)
      • PT (PT)
      • RU (RU)
      • 日本語 (JA)