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.
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Business process modeling (BPMN)
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Risk management
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Applicability assessment and requirement implementation
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Product management
Основные преимущества
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.
Solution Overview
Solution Overview
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Know some success stories
Рекомендуемые источники
Электронная книга
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.
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.
Электронная книга
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.