Cognition for Quality, Regulatory, and Compliance

Quality, Regulatory, and Compliance Management – Simplified.

Delayed submissions, failed submissions, and subsequent audits disrupt company operations, significantly impacting revenue. 

Our design control software—specifically created for medical device manufacturers—streamlines regulatory and compliance management while enhancing data integrity, so that you reach the submission phase sooner and are assured of audit readiness. 

What You’ll Experience

Far too many quality, regulatory, and compliance leaders are hindered by disconnected data, manual traces, and documentation errors. We provide automated trace matrices and guided templates to ensure compliance. 

Plus, you’ll save time with submission-and audit-ready reports that you can export instantly in the required formats.

  • Guided workflows for compliance with ISO 14971, ISO 13485, and 21CFR820.30 
  • Built-in templates for risk management planning, preliminary hazards analysis, use error analysis, FMEA, and product risk analysis
  • Central library of harms and hazards, referenced across projects to ensure consistency
  • Submission-ready reports can be exported instantly in the required formats (ensuring consistency between internal data and exported documents)
  • Automated trace matrices across even the most complex projects 
  • Out-of-the-box and configurable risk management processes specifically for medical device design and development
  • Enhanced data integrity with tightly integrated risk management, requirements management, and test management 
  • Easy imports of data/documentation from Word, Excel, or other domains
  • Seamless integration with other systems to ensure appropriate data/document linkages 
  • Embed global and/or regional regulations and standards, and easily adapt to regulatory changes
  • Design review and approval cycles with electronic signatures with user/admin privileges

Key Benefits

Manage Risk – At Every Level

Tightly integrate risk with requirements and tests to ensure data consistency throughout all phases—enabling you to deliver more compliant products to market.

File Documents Faster

With integrated risk management, requirements management, and test management, you can start compiling what’s needed for regulatory approval sooner—speeding your time to submission.

Be Audit Ready

Automatically generate and export master trace matrices and documents for the design history file, technical documentation records, audits, and more—in the formats required by regulatory bodies. 

What Our Customers Say

Featured Case Studies

Learn how our design control solution is helping other R&D leaders maximize efficiencies, save resources, and enhance data integrity. 

Learn what streamlined quality, risk, and compliance management can do for your company.

Helpful Resources

Why Many Medical Device Companies Are In Danger of Risk Analysis Missteps

Cultivating Risk-Focused Design Instincts