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Stop Manually Creating FDA Documentation, Start Automating

Hardware design and manufacturing in the medical field is only half the battle - building a robust quality system to ensure reliability and compliance often consumes a major portion of your engineers time. CoLab allows engineering teams to focus on the engineering while automating DMR and device history documentation.

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"The app was amazing to have on the shop floor during our build. I would say 2 thumbs up!"

Engineering Manager
Fortune 500 Industrial Equipment Leader

“By having a universal issue tracking system and an API we can work with, I see CoLab integrating well with our digitization plans”

Engineer
Top 10 Global Energy Company

Medical device compliance and quality systems are time consuming and error prone.

Designing innovative new products, and prioritizing the highest standards for quality cannot be siloed activities. CoLab allows medical device design teams and their manufacturing partners to work in a common location where they can expedite their process and automate much of the Device Master Record and History Documentation to streamline FDA processes and approvals.

Accelerate Regulatory Approval

Comprehensive Documentation

Developing innovative medical equipment technology involves intense regulatory review and careful process documentation. The industry leading process today puts most of this burden directly on your engineering team. By tracking changes, reviews and issues in CoLab, you can ensure your documentation is always up to date and reduce the amount of time you spend creating material for the FDA

Compliance and Quality Leader

Exceptional quality and compliance processes in medical device design and manufacturing is critical. With CoLab, the quality of the product, your communications and resolutions are all centralized in one location so no issue goes unresolved. With simple access, all stakeholders can be involved at any stage to help you build better products. Reduce delays, avoid costly mistakes, maintain compliance.

Agile and Collaborative

Eliminate budget overrun and eliminate preventable engineering changes. CoLab enables teams to collaborate from day 1 and have the visibility they need to catch and resolve issues before they become expensive change orders.

Accelerate Regulatory Approval

Developing innovative medical equipment technology involves intense regulatory review and careful process documentation. The industry leading process today puts most of this burden directly on your engineering team. By tracking changes, reviews and issues in CoLab, you can ensure your documentation is always up to date and reduce the amount of time you spend creating material for the FDA
Exceptional quality and compliance processes in medical device design and manufacturing is critical.With CoLab, the quality of the product, your communications and resolutions are all centralized in one location so no issue goes unresolved. With simple access, all stakeholders can be involved at any stage to help you build better products. Reduce delays, avoid costly mistakes, maintain compliance.
The global demand for innovative new medical products is rising, and so is the pace at which these solutions must hit the market. With this shift, many companies are turning to agile development to design and build their innovative  hardware. CoLab gives teams a simple, connected and purpose-built platform to design, review and manufacturing. CoLab shortens review cycles from months to days and eliminates millions of dollars in costly change orders and non-conformances for new products.

Designing and manufacturing a new medical device is hard enough, let us help you with the overhead and approvals.

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Solutions

Lifecycle Issue Tracking

Built for engineering workflows from early design through production

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3D Design Review

Simple, integrated reviews with industry-leading security

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Collaborative Drawing Reviews

Redline any PDF with your team together, in real-time

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3D Work Instructions

Clear work instructions that provide all of the context instantly

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Program Task Management

Coordinate change packages reviews with all stakeholders

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Supply Chain Collaboration

Simplify your supply chain, without the IP risks

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CoLab Software

Engineering Review & Issue Tracking, Solved.