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Product
A modern QMS built for modern teams
Nemedio’s product suite is purpose-built to support the medical device development process. Everything you need to get a QMS up and running at lightning speed.
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Product
All the features you’ll need for fully integrated quality management.
Quality management tools and features that are purpose built for efficiency and ease of use —
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to learn more.
Document & Change Control
Training Management
Supplier Management
CAPA & Complaints
Design Controls
Risk Management
V&V Testing
Project Management
Document & Change Control
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• Permissions Assignment
• Web Based Text Editor
• Document File & PDF Upload and signatures
• Administrative & Change Order based releases
• Change Order Training Impact Assist Tool
• Point of use effective views
• Obsolete document management
• Document exporting
Training Management
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• Create & Manage Employee Training Plans
• Create Multimedia based course content
• Manage Training assignments and records
• Training Notifications & Reminders
• Smart Training Impact Assessment tool automatically manages creation of training assignments
• Access to Standard Course Content
• Training Dashboard
• Training-only licenses
Supplier Management
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• Request and approve suppliers
• Maintain approved suppliers list
• Revoke Supplier Qualifications
• Automatic Qualification Expiration & Renewal Reminders
• Configuration of Risk-Based Requalification Date Parameters
• Manage Audit Plans and Reports
• Supplier Management Dashboard
• Supplier view-only document access control-
coming soon
CAPA & Complaints
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Design Controls
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• Requirements and User Needs Management
• Backlogging of Design inputs for agile-style development
• PLM style requirement history and tracing
• Design and Code Review management
• Design Output File Management & Approvals
• Intuitive trace matrix development
• Tracing of regulations and standards to design inputs
Risk Management
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• Guided Risk analysis process to support compliant risk management
• System hazard risk analysis functionality
• Automatic calculation of risk priority codes based on configurable severity and likelihood settings
• FMEA management
• Risk Trace Matrix management
• Automatic aggregation of risk related requirements and tests
• Risk/Benefit analysis tools
Testing
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• Develop product and non-product verification and validation protocols
• Aggregate protocols into a test plan
• Manage executed test protocols
• Aggregate executed protocols into a test report
• Create and manage test defects and deviations
• Full-circle integration of defect reporting and change control
Project Management
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• Create and assign tasks to users
• Link tasks to items
• Integrated task management with Change Control and CAPA
• Pre-filled project task templates to jumpstart your efforts
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