Compass can work for your business without requiring dedicated administration personnel devoted to configuration or customization, thus allowing you to focus on product development rather than administrative tasks. Compass offers pre-configured document templates specific to medical device product development using our guided compliance approach. Data-centric working tables are also available for teams used to flexible data entry, enabling filtering and table organization in a personalized format, optimizing individual work. This data is integrated automatically into the same templated documents, enabling each team member to work in the space that is most productive to their expected tasks or outputs. This means your product development process is documented in a submission-ready format, while making data entry efficient.

Structured data contains specific information, each with a unique identifier. For structured data to be valuable, it may be used in multiple locations, exist over time, be reusable, be connected to child/parent/peers, and enable action at a distance. Given the unique ID setup, if you need to update the central property, the update will be pulled or pushed through to all locations that use it. This is exactly how Compass treats your product development data.

Structured data has many benefits, including:

• Establishing a single source of truth
• Increasing compliance
• Reducing errors
• Reducing time-to-market
• Improving data integrity
• Reducing resource costs
• Reducing IT Burden
• Increasing report quality
• Preparing for the future

Compass provides medical device companies an advantage with its risk-focused approach that
places high emphasis on the value of tightly integrating risk management in the design control
process with requirements and tests. Compass supports the risk management process defined
in ISO 14971 and has the ability to embed global and/or regional regulations and standards
to guide users through the risk analysis process. The templates in Compass ensure process
consistency and enable stepping users through the process to produce comprehensive and useful
assessments. Risk becomes an active part of the development process with integration with
requirements and testing, not just a paperwork exercise to “check the box”.

Compass guides you through the process of creating a:

• Risk Management Plan
• Preliminary Hazard Analysis
• Use Error Analysis
• Design FMEA
• Design Risk Analysis
• Benefit Risk Analysis

Unlike other risk management tools, Compass not only manages individual risk data points, like hazards, hazardous situations, and harms, but it also maps out the sequence of events that can ultimately lead to a patient being harmed. While the individual risk data points can be stored in a library and reused, it is this unique sequence of events that must be mitigated. Data sharing across supporting tools creates a seamless risk management system where sequences originating in both normal and fault conditions can be assessed in a single risk analysis.

To best control risk, risk control measures must be implemented into the design. In Compass, risk management and requirements management are tightly integrated. In concert with test management, this enables real-time assessment of the impact of every change across every function.

For more on our approach to Risk Management in Compass, click here.

Traces are used for a variety of reasons, from audit support, to proving that outputs align to inputs, to ensuring that all user needs are covered, and that testing is complete. By creating traces as data is added, copy-paste errors are eliminated, and time to build large trace tables becomes inconsequential. Compass builds best practice trace matrices via pre-configured templates, enabling connections to be established as data is added and automatically creating output documents and views. Changes in data content are instantly available across the entire project so that information is up-to-date without hunting for cross-references. Changes can be assessed for impact analysis at all connection points with easy visualization of the relationships. Compass trace matrices can be adapted to an organization’s SOPs and can be exported for reporting purposes.

For more on our unique trace functionality, click here.

Compass has been designed with the unique needs and requirements of medical device development in mind. This includes processes, techniques and documents tailored to support the complex regulatory, safety, and performance standards of the medical device industry.

In Compass, documents can be prepared and exported in a format that supports the specific requirements for submission to regulatory bodies or other relevant entities without the need for post-export manipulation.