BRING PRODUCTS TO MARKET FASTER WITH LESS RISK
Guided Compliance® for Medical Device Product Development
Poorly connected data is an inherent challenge of product development. Manual processes and the lack of linkage/connection between all compliance data makes product development— and critical traceability— highly error-prone, time-intensive, expensive, and complex. However, when technology and process meet to create and maintain connections between diverse data, products can get to market faster with less risk.
Compass is a SaaS solution purpose-built to connect data across all functional areas of medical device product development and automate a complex workflow between those inter-connections to ensure compliant development. It provides an adaptable set of templates for the entire product design control process: risk, requirement, and test management, from user needs to validation. Saving time and resources, it maintains documentation and supports submissions as well as providing automatic generation of the master trace matrices for the Design History File (DHF).
REDUCE TIME TO MARKET WHILE ENSURING COMPLIANCE
Compass, powered by our Cockpit Platform, is the only solution that truly integrates risk, requirement, and test management for a fully automated design control process. It includes built-in, enforced processes for quality management and adaptable document management functionality to meet all of your reporting and regulatory submission needs.
Regulatory Compliance Is Not Optional
Compass SUpports Compliance with Major Industry Standards and Regulations.
MANAGE DESIGN CONTROLS WITH TOTAL TRACEABILITY
Compass includes built-in mechanisms for allocating, linking, and tracing requirements, risks, and tests to help teams see the numerous connections from User Needs and Validation through to Design Outputs, Risk, and Verification. It automatically pulls in the data to generate complex master trace matrices, with tens of thousands of traces within a single table, that can be exported and submitted as part of the Design History File (DHF).
Automatic Generation of a Master Trace Matrix for Multiple Requirement Levels
Automatic Generation of a Detailed Trace for an Individual Requirement
Why Do Leading Medical Device Companies Choose Compass?
- Guided Compliance supports efficient, evidence-based product development
- Complete traceability across all functional areas provides a single point of truth so that every action is accounted for and easily traced/auditable
- Out-of-the-box template functionality with the ability to adapt to your processes
- Automated enforcement of processes allows for alignment with quality management systems
- A single solution to author, approve, and archive Design History File (DHF) content
Request a Demo
See How Compass Can Help You Get to Market Faster, With Complete Traceability.