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.
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.
Effective Bill of Materials (BOM) management.
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.
How to overcome challenges and boost results in the medical devices industry
How will ISO 13485:2016 impact your relationship with suppliers?