Back to top
SoftExpert no LinkedIn SoftExpert no Twitter SoftExpert no Facebook SoftExpert no Youtube
Medical Devices


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.

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.

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.

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.


The migration to the Web version was easy and brought only advantages such as the streamlined management of the processes underway.

Adriano Einsenhut - Quality Coordinator


Download Center

Select the materials of interest and fill out the form to download:
Please wait...

Screenshots (Click to Enlarge)

Business process modeling (BMPN)
Risk assessment
KPI management
Maintenance schedule
Asset management
Product structure


  • 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.

About SoftExpert

SoftExpert is a market leader in software and services for enterprise-wide business process improvement and compliance management, providing the most comprehensive application suite to empower organizations to increase business performance at all levels and to maximize industry-mandated compliance and corporate governance programs.

Founded in 1995, SoftExpert has a rich history of innovation and growth as a true industry leader. More than 300,000 users from 2,000 organizations worldwide trust SoftExpert applications to ensure the highest standards of efficiency, quality and innovation for their products, services and processes.

By streamlining and integrating all levels and operations, SoftExpert applications also enable organizations to address an ever-increasing variety and number of international standards, laws and regulations that affect business operations by delivering enhanced compliance capabilities based on industry-specific best practices.

SoftExpert solutions are used by leading corporations in all kinds of industries, including consumer products, automotive, food and beverage, mining and metals, high tech and IT, energy and utilities, government and public sector, financial services, transportation and logistics, healthcare, education, medical devices and many others.

Along with its extensive network of resellers spread across all continents, SoftExpert also provides hosting, implementation, post-sales support, and validation services for its solutions to ensure that customers realize the maximum value from their investments.

Follow Us

Comercial -   Partners

Ombudsman -

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