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
Rated 4.7 on

Are you fed up with your clunky quality system?

Unifize's unique approach to collaboration brings people, processes and data together in a familiar, easy-to-use chat based environment.

Here’s how Harmonic Bionics slashed time to market by 80%

Denis Machoka
Director of Quality & Regulatory Affairs
“I always get the latest information without having to open another email, without having to go to a different tool.”
Michael Hogan
Mechanical Engineer
“Everybody's looking at the same files. Everybody has the same chat history. There's no obfuscation of what's going on!”
Quality Assurance
Clarissa Archer
Quality Manager
“The really big part of Unifize is the the ability to connect not only people but information.”

We didn’t re-invent the wheel, just quality management

Faster time-to-market

Map Unifize to your processes and streamline workflows, process automation, and prioritization
Fewer meetings

Less meetings with in-app collaboration, real-time updates, and decision logs
Full visibility through real-time reporting, milestone tracking, and customizable analytics
Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices

Flexible and powerful solutions that comply with external standards

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.
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.
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

Streamline your workflow with Unifize

Experience the power of collaborative work management

Platform Features

Process Builder

Charts & Reports Builder

Automation Robot

User Groups

Reminder & Escalations

Conditional Workflows

checklists & forms

Create structured forms and checklists.

Real-time collaboration

Foster instant teamwork and communication.

owners & teams

Assign ownership and manage teams seamlessly

Tables & Reports

Generate tables and reports for data analysis

Analytics & Charts

Visualize data with analytics and charts

document management

Collaborate in real-time on docs and revisions

email integration

Seamlessly integrate email communication

No-Code Configuration

Process Builder

Tailor workflows without coding

Charts & Reports Builder

Customize charts and reports effortlessly

Automation Robot

Automate repetitive tasks and processes

Reminder & Escalations

Set automated reminders and escalation rules

Conditional Workflows

Create flexible workflows based on conditions

Dashboard Configuration

Personalize dashboards to suit your needs

User Groups

Manage user access and permissions

Access Anywhere

Unifize mobile app

Enjoy mobile access for on-the-go productivity

Unifize Web app

Access via web browser for desktop use

unifize lite

A simplified interface for quick and easy tasks

Secure Cloud Infrastructure

Conversational Data

All your conversations, safely secured

Process & Metadata

Protect process and metadata information

File & Document Store

Securely store files and documents

Configuration Data

Safeguard critical configuration data

Integrates seamlessly with all your tools and workflows.

Adapt Unifize to your existing CRM, ERP, CAD and SSO infrastructure via standard integrations and Open APIs.

Don’t see your tools here?

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Starting out with eQMS?

Kickstart your quality processes effortlessly with our eQMS software, including essential tools right from the start.

1:1 Founder Demo

Moving from a different solution?

Seamlessly transition from your current solution to Unifize for medical device quality management in under 30 days

Get a 1:1 demo

Starts at $1850/month

Book a free call

Starts at $1850

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