White Paper

Modernizing the Approach to Risk Analysis in Medical Device Development

Risk Analysis Spreadsheets Do More Harm Than Good

As the complexity of medical device risk analysis grows, the limitations of spreadsheets becomes more apparent.

Modern software solutions for risk analysis can help medical device manufacturers achieve greater data consistency, accuracy, and integrity.

Download the white paper to see the benefits, including:

Dynamic Data Handling

Utilizing the power of databases, modern solutions provide connected and reusable data, maintaining data consistency throughout the analysis process.

Audit Trails and Data Control

Modern tools automatically create audit trails for data changes, enhancing quality management. Workflow features allow for data review and approval, preventing accidental modifications.

Traceability and Integration

Modern risk analysis solutions seamlessly integrate design and test data, enabling robust traces between tasks, controls, requirements, and tests, to promote more robust traceability.

ISO 14971 Compliance

Cognition’s software solutions are specifically designed to support the medical device risk management processes described in ISO 14971 with full integration of risk, design, and test data.

Access the White Paper

Fill out the form and see how Cognition helps MedTech innovators modernize their approach to risk management.

FMEAs Are Not Risk Analyses. See Why It Matters.

FMEA and risk analysis are separate but connected processes, yet the terms are often used interchangeably. Download the white paper to see how using FMEA as a risk analysis technique can compromise the integrity of medical device R&D.

FMEA-based risk analysis is:

Incomplete | Inconsistent | Ineffective

Mitigate Risk with Cognition’s Compass® SaaS Solutions

Cognition’s Compass® software supports thorough risk analysis throughout life sciences product development, helping set up medical devices and drug products for regulatory success.

MedTech

Compass® MED helps elevate structured data, risk management, and design control for medical device development.

Biopharma

Compass® BIO merges CMC, quality, and risk data to support regulatory compliance for Biopharma products.

Combination Products

Compass® PRO helps streamline CMC, quality, and risk data to promote compliance for combination products.

Say Goodbye to Spreadsheets

Access the white paper to learn why the leading MedTech innovators are leaving spreadsheets behind, and getting more accurate, more trustworthy data in the process.