New Product Release: Compass® PRO for Medical Device Product Development
Latest News: Cognition Raises $6,000,000 to Accelerate Product Development and Customer Expansion
Latest News: Cognition Welcomes Medical Device Sales Executive to Lead Rapid SaaS Customer Expansion
Whitepaper Release: Modernizing the Approach to Risk Analysis in Medical Device Development

MAKE DESIGN CONTROLS EASY

Goodbye, spreadsheets,
Hello, connected information.

Cognition provides R&D and Quality Leaders with a medical device design control software platform that helps meet regulations faster with real-time traceability, guided design controls, and change once, update everywhere functionality – turning manual and disconnected data into structured submissions that enable them to get to market faster.

GLOBAL MEDICAL DEVICE MANUFACTURERS

RESEARCH & DEVELOPMENT LEADERS

QUALITY ASSURANCE, REGULATORY AFFAIRS, AND SYSTEM ENGINEERS

TRUSTED BY

“Errors in our spreadsheets aren’t caught in time.”
“We’re missing dates for submissions because Doc1 CellAJ-278 isn’t linked to Doc17 CellAH118.”
“Time we don’t have is wasted creating, editing, and verifying spreadsheet data – all by hand.”

Your product development deserves to get error-free regulatory approvals.

As regulations continue to change, medical device manufacturers’ product development is often stalled by submission iterations, audit findings, or regulatory warnings, caused by disconnected data, manual traces, inadequate processes, and documentation errors.

• Failed audits

• 483 Citation

• Regulatory warning letters

• Rework, delays, and cost overruns

Increasing compliance complexity, changing regulations, and competitive pressures make relying on complicated spreadsheets no longer the safest approach to compliance.

5

OF THE TOP 6 MEDICAL DEVICE COMPANIES USE COGNITION

275K+

PRODUCTS SUPPORTED

ISO 14971 & ISO 13485

SUPPORTED STANDARDS

The world has changed.

Document-based approaches to product development no longer work.

The outdated document-based approach to product design is no longer effective. It takes too long, is costly, and is prone to errors. Successful medical device manufacturers are turning to an information-driven approach, which utilizes connected data and real-time traceability that streamlines the process.

OLD
Document-Driven
PRODUCT DEVELOPMENT NEW
Information-Driven
Disjointed Design/Risk
Development Methodology
Integrated Risk
Words on Paper
Objects
Clickable Elements
Silos
Regulatory Audit
Centralized Information
Hand Typed
Traces
Automated
Disconnected
Data
Connected
Documents in Folders
Libraries
Linked Objects
Serial
Reviews
Collaborative

Stop editing spreadsheets.

Start information-driven design.

You shouldn’t have to recreate data that already exists.

WHY COGNITION

Meet regulations easier.

Unlike other design controls systems that simply replicate traditional documents and spreadsheets, Cognition takes a structured data approach combining risk with test and requirements data so you can easily build relevant connections between data items, automatically create complex trace matrices, and export formatted documents instantly.

Get real-time traceability.

Providing a 360-degree view of your project.

With real-time and historical views of risks, requirements, and tests for the most informed planning, development, and impact analysis.

Change once, update everywhere.

Create a single point of truth.

For every data item – if a requirement is changed in the product requirements document for example, it is automatically updated throughout – ensuring data integrity.

See the impact of design changes.

Reduce the likelihood of information inconsistencies.

With fully traced data items, impact analysis becomes second nature. The effect of changes on upstream and downstream data connections can be easily viewed before making a change.

Reduce your data administration burden while increasing the quality of your product.

Cognition’s platform helps you manage design controls for device requirements and related risks, simplifying regulatory submissions, and audit preparations while accelerating time to market.

COMPASS® / COMPASS® PRO

Design Controls Platform for Medical Device Companies

COMPASS® BIO

Application Suite for Pharmaceutical Companies

GUIDED COMPLIANCE

Why Companies Rely on Cognition
“Our New Risk Module for Cockpit Enterprise enables us to effectively manage risk.  The “plug-in” nature of the new risk module means we will have simpler implementations with faster benefits. Ultimately, we are saving time and seeing better risk management.”
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Ian Bennett, IT R&D Leader, Smith & Nephew
“With Cognition, we instantly gained access to document templates, workflows, and a knowledge base, which guided us to perform our processes in better compliance with critical standards and good engineering practices.”
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Miklós Czeller, R&D Director, Mediso
“Cognition’s solution ensures teams spend significantly more time focused on productive work, rather than building and maintaining documents and complex traces. This allows us to run lean and still accelerate our time to market.”
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Chris Henry, Senior Manager, Software Quality Engineering, Epic Sciences
“Before Cognition we were manually creating data and data connections that were maintained in paper DHFs that were difficult to scale. Now we are able to create the same data and links in a way that allows Zimmer Biomet to easily maintain large trace matrices.”
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Shaun Cronin, PLM Associate Director, Zimmer Biomet

Connected design controls are easy with Cognition.

RESOURCES

Don’t let errors in design documentation hold back your regulatory approvals.

Modernizing the Approach to Risk Analysis in Medical Device Development

The limitations of spreadsheet-based analyses are becoming increasingly evident

Digital Transformation: A Global Shift in Data Management

Managing medical device product development data in Excel or Word is no longer enough

Request a Demo

Create products with compliance at the forefront of design.