Compass MED 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 medical device industry’s complex regulatory, safety, and performance standards. This functionality is based not only on standards and regulations (such as ISO 13485 or 21 CFR 820), but also from industry experts, and feedback from our customers, resulting in a solution that is not only compliant but also follows best practices and industry standards.

Compass MED 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 from early on in the development process. Compass MED supports pre- and post-mitigation and the risk management process defined in ISO 14971. It has the ability to embed global and/or regional regulations and standards to guide users through the risk analysis process. The out-of-the-box templates in Compass MED ensure process consistency by guiding users through the proper steps that produce comprehensive and useful assessments. Risk becomes an active part of your development process through integration with requirements and testing, far more than just a traditional “check the box” exercise.

Compass MED guides you through the process of creating a:

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

Unlike other risk management tools, Compass MED 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 identified. By defining the sequences leading to hazardous situations, or reducing the likelihood of hazards leading to harms, risks can be mitigated or in some cases removed. 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, control measures must be implemented into the design. In Compass MED, risk management and requirements management are tightly integrated. In concert with test management, this enables real-time assessment of the impact of every risk control across every function.

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

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 MED 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

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 automating traces as data is added, copy-paste errors are eliminated, and time to build large trace tables becomes inconsequential. Compass MED 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. Additionally, companies can create their own trace formats to collate the data that they need into the most useful format. 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 MED 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.

The status of key deliverables is available to be visualized in a consolidated and easy-to-digest way. Users can explore critical project information using the dashboards and see a snapshot of the project status at a glance, with a focus on key areas. Landing pages can be personalized to have information important to users instantly available upon login and can differ by project. Reports and filters enable users to easily find missing information without tediously reviewing data to find missing linkages, undocumented requirements, or status.

Compass MED provides users the ability to work in either a tabular data-centric or document-centric environment. It enables users to access the same information in the format that works best for them. To ensure data integrity and quality, information entered into workspaces instantly becomes part of the document. This means your product development data is documented in a submission-ready format while making data entry efficient.

Documents, reports, and traces are created through customer-defined, reusable templates so users will always have the approved documents needed for their use and for delivery downstream to regulatory or other groups. The power of structured documents becomes clear with not only required document elements but embedded help. Items such as formatted document sections, designed data tables, electronic signature pages, narrative content, instant export, and compatibility with external systems. No post-processing or external software is necessary.

Compass MED 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 MED offers pre-configured document templates specific to medical device product development using our guided compliance approach.