Nemedio | Product

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

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

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.

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 — book a demo to learn more.

Document & Change Control

Training Management

Supplier Management

CAPA & Complaints

Design Controls

Risk Management

Testing

Project Management