Cut Cost of Poor Quality (CoPQ) by 20% with AI
Unifize is the only AI-powered quality management software designed to accelerate medical device development by fostering real-time collaboration across teams and automating compliance-critical workflows.
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AI-powered Medical Device eQMS
Built for compliance
An eQMS purpose-built for medical device companies
Unifize streamlines your medical device product development while keeping your teams compliant.
ISO 13485
ISO 62304
ISO 14971
ISO 15189
ISO 60601
21 CFR Part 820
21 CFR Part 11
510(k) Submission
Legacy eQMS systems are clunky and lack intelligence.
Why Unifize?
Unifize's unique approach to collaboration brings people, processes, and data together in a familiar, easy-to-use chat-based environment, enhanced with AI-driven insights and automation.
Here’s how Harmonic Bionics slashed time to market by 80%
Customer Success Story
Leadership
“I always get the latest information without having to open another email, without having to go to a different tool.”
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Engineering
“Everybody's looking at the same files. Everybody has the same chat history. There's no obfuscation of what's going on!”
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Quality Assurance
“The really big part of Unifize is the the ability to connect not only people but information.”
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The impact of Unifize, as observed by customers
Measurable Impact
40%
Faster CAPA and NC closure
Unifize’s AI guides root cause analysis and automates follow-ups to close issues faster.
Unifize’s AI guides root cause analysis and automates follow-ups to close issues faster.
75%
Reduction in complaint resolution time
AI parses complaint emails, initiates workflows, and connects teams to act in hours—not weeks.
AI parses complaint emails, initiates workflows, and connects teams to act in hours—not weeks.
25%
Reduction in CoPQ
By eliminating rework, delays, and compliance gaps, Unifize drives measurable operational savings.
By eliminating rework, delays, and compliance gaps, Unifize drives measurable operational savings.
35%
Increase in employee productivity
AI takes care of the admin—so your team spends more time solving problems, not chasing updates.
AI takes care of the admin—so your team spends more time solving problems, not chasing updates.
Flexible and powerful solutions that comply with external standards
Modules
Our library of 100+ process templates give you the ability to control and scale your quality processes with your business.
Document Management
Control, track and manage documents required for compliance with FDA Part 820 and ISO 13485.
Change Control
Manage changes to device design or production process with proper review and approval.
Live Document Editing
Real-time collaboration on documents viaintegrations to Sharepoint / Office 365
Approval Workflows
Implement approval workflows with 21 CFR Part 11 compliant electronic signatures.
Revision Management
Ensure proper documentation, review, approval and training of all changes & revisions.
Training
Track and ensure employee training on procedures, regulations, and device handling.
View Demo Walkthrough
“Unifize helped me drive down our testing costs from $146k to $65k in two months.”
Jesse Kolstad
Director of Quality, Biovation Labs
Traceability Matrix
Establish and document traceability between requirements, tests, and design elements.
Risk Management
Identify and mitigate risks during device design and production stages in compliance with ISO 14971.
Design History File
Keep a history of all design inputs, outputs, verification/validation activities & risk management.
Change Requests & Orders
Controlled, approved management of changes to device design or production process.
Regulatory Submissions
Ensure timely regulatory submissions through streamlined document preparation and submission.
CAD & Integrations
Integrate with other systems and tools, such as ERP systems, CRM systems, and collaboration platforms.
View Demo Walkthrough
"Unifize allowed us to customize it to fit our needs, unlike struggling with rigid software. A game-changer!"
Clarissa Archer
Quality Assurance, Harmonic Bionics
NCs / Defects
Identify, document, and resolve non-conformities; implement corrective/preventive actions.
Disposal Actions
Streamline quality processes by creating, tracking and assigning disposal actions with ease.
Root Cause, CAPAs & 8Ds
Identify, address, and prevent quality issues using root cause analysis, CAPAs, and 8Ds.
Inspections
Validate that product design and production processes produce items meeting specifications.
Customer Complaints
Capture, document, and track customer complaints, initiate investigations, implement CAPAs
Audit Management
Plan, schedule, and conduct internal, layered and external audits for compliance verification.
View Demo Walkthrough
"Unifize simplifies tracking, linking non-conformance, and change control effortlessly for clarity and efficiency."
Clarissa Archer
Quality Assurance, Harmonic Bionics
Supplier Documentation
Centralize supplier documentation, enhancing visibility and control over supplier-related information.
Raw Materials & Parts Specs
Collaborate with vendors on RM specs, revisions, work instructions, test specs, regulatory requirements.
Supplier Corrective Actions & 8Ds
Efficiently manage supplier corrective actions and 8D reports to drive supplier quality improvements.
Supplier Portal
Real-time, secure collaboration with supplierson audits, CAPAs, 8Ds, design transfer & product/RM specs.
Supplier Scorecards
Evaluate and monitor supplier performance with scorecards, fostering continuous improvement .
RMAs / Returned Goods
Simplify the management of returned goods and RMAs, ensuring quick resolution and customer satisfaction.
View Demo Walkthrough
"Unifize helped us save time and money by streamlining robot assembly with quality parts and improving vendor communication."
Clarissa Archer
Quality Assurance, Harmonic Bionics
Electronic Lot Records
Capture critical lot info such as materials used, manufacturing steps, calibration, QC tests, releases.
Contract Manufacturing
Collaborate in real-time with your contract manufacturers to ensure quality and compliance.
Device Manufacturing Record
Manage device specifications, manufacturing processes, labelling, packaging and QA procedures.
Work Orders & Routing
Efficiently manage work orders and routing, optimizing production processes and resource allocation.
Calibration & Maintenance
Manage calibration and maintenance schedules for equipment, and track maintenance activities.
QR Code Tracking
End-to-end traceability of FG/RM lots, rejections using printable labels/PDFs with QR codes.
View Demo Walkthrough
“Unifize helped me drive down our testing costs from $146k to $65k in two months.”
Jesse Kolstad
Director of Quality, Biovation Labs
Integrations
Curious to unify your other systems with our platform?
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Built on a platform engineered to enhance visibility, flexibility, and accountability
Platform
Configuration
From role-based dashboards to conditional workflows, Unifize’s no-code capabilities make it easy to configure the platform to meet your team’s specific needs.
No-Code
Process Builder
Role-Based Home Screens
Configurable Dashboards & Reports
Access Control & Permissions
Configurable Checklists & Forms
PDFs with Embedded QR Codes
Conditional Logic on Checklists & Forms
Collaboration
Integrate conversations and workflows effortlessly. With chat, role-based access, and vendor portals, Unifize keeps teams connected and productive.
Chat Driven Process Records
Vendor /
Customer Portal
eSignatures (CFRPart 11 Compliant)
Email To / From Records
Mobile & Tablet Enabled
Real-time AuditTrail
Manage Groups
& Roles
Dynamic Teams & Ownership
Unifize Lite
Automation
Automate routine tasks and eliminate inefficiencies with Unifize’s rule-based workflows, smart notifications, and approvals.
Revision Management / Version Control
Archiving & Retention Management
Record &
Document Routing
Calculations
Record Creation
From Email
Email & Phone Notifications
Reminder &
Escalation Workflows
Custom
Auto-Numbering
Update Metadata
& Record Titles
Auto Add People
& Groups
Approval Workflows
Integration
Ensure connectivity with your tools, enabling smooth integration with email, SharePoint, and other systems you already use.
Unifize API Access
Slack Integration
SSO/SAML Authentication
Sharepoint / OneDrive
Email Integration
Analytics & Reports
Build highly configurable reports and dashboards, and track the metrics and KPIs most important to your business in real-time.
Configurable Reports & Dashboards
Cycle Time Tracking
Real-Time
Metrics & KPIs
Metrics & KPIs
Custom Reporting Templates
Role-Based Dashboards
Enterprise-Grade Security
Built with robust security measures, Unifize safeguards your data with encryption, compliance-ready features, and detailed audit capabilities, ensuring your operations remain secure.
Role-BasedAccess Control
CFR Part 11 Compliant eSignatures
SOC-2 Compliant
Data Storage
Comprehensive
Audit Trails
Enterprise-Grade Encryption
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