MES for Medical Devices & Diagnostics
Manufacture with 100% US FDA 21 CFR Part 11 Compliance
FDA certification requirements are constantly changing. NGIMES is a cloud-based solution that helps medical device and diagnostics corporations configure their systems while reducing costs and accelerating FDA compliance.
Schedule Your DemoWhy NGIMES for Medical Devices?
Meet evolving FDA requirements while reducing costs and improving productivity with cloud-based manufacturing execution
Complete FDA Compliance
Quickly configure processes to meet specific FDA requirements with electronic signatures, Device History Records (eDHR), and complete audit trails built-in.
- US FDA 21 CFR Part 11 compliant
- Electronic signatures & eDHR
- Simplified cloud auditing
Paperless Manufacturing
Enable paperless manufacturing with everything stored in cloud memory. Complete visibility and control across varying manufacturing locations from any device.
- 100% paperless operations
- Real-time shop floor visibility
- Higher yields and quality
Reduced Costs
Lower infrastructure and personnel costs with no on-site IT maintenance needed. Easy setup that can be completely modified to fit your business needs.
- Significant infrastructure savings
- Reduced IT maintenance needs
- Quick setup and configuration
Complete Medical Device Manufacturing Solution
Everything you need for compliant, efficient, and profitable medical device manufacturing
What You Get
- US FDA 21 CFR Part 11 regulatory compliance
- Electronic signature and device history record (eDHR)
- High-performance process control
- Higher yields and paperless manufacturing processes
- 100% real-time shop floor visibility
- Real-time business intelligence and analytics
How You Benefit
- Significant infrastructure cost savings
- Minimized product recalls
- Reduced need for IT maintenance expertise
- Improved process and productivity quality
- Fewer barriers to ROI and improved efficiencies
- Enhanced compliance with US FDA
Take Control of Your Business
Complete Visibility
Being on the cloud allows medical device and diagnostic companies to complete more work. Business leaders achieve complete visibility and control across varying manufacturing locations at any time.
Monitor productivity from any device with Web access. BI data can be accessed instantaneously, so managers are armed with real-time data, optimizing the decision-making process.
Simplified Operations
NGIMES enables paperless manufacturing, as every piece of information is stored in memory. With no on-site IT maintenance needed, your company can lower personnel costs while improving productivity.
NGIMES is easy to set up and can be completely modified to fit your business' specific needs.
Ready to Enhance Your Medical Device Manufacturing?
Contact Atachi today and find out what cloud-based solutions can do for your medical device or diagnostics business
Talk To Us Today About Your MES Needs