GUIDED COMPLIANCE® TO BRING SAFER PRODUCTS TO MARKET FASTER
Compass is a pre-configured, out-of-the-box, SaaS solution purpose-built to connect data across all functional areas of medical device product development, leveraging regulations such as 21 CFR 820.30 as well as standards ISO 13485, IEC 62366, and ISO 14971 as the foundation of the software design. It enables compliant product development by ensuring the process of authoring, reviewing, and releasing is enforced via workflows and built-in document templates, and automates a complex workflow between those interconnections to ensure compliant development. It provides an adaptable set of document templates for the entire product design control process from user needs to validation, with a focus on risk, requirement, and test management. Saving time and resources, it maintains documentation and supports submissions as well as provides automatic generation of the master trace matrices and documents for the Design History File (DHF), Technical Documentation Records, or audit support.
Compass is best suited for small- to medium-sized medical device companies looking for guidance on how to bring their products to market with less risk. Compass offers guided compliance that is fully functional out of the box.
THERE IS A BETTER WAY TO MANAGE YOUR DATA
LEARN WHY COMPANIES ARE LEAVING EXCEL AND WORD IN THE PAST AND SWITCHING TO COMPASS FOR PRODUCT DEVELOPMENT DATA MANAGEMENT.
COMPASS CORE FUNCTIONALITY
WHAT OUR CUSTOMERS ARE SAYING ABOUT COMPASS
WHAT SETS COMPASS APART
Template-Based, Out-of-the-Box Functionality
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 templates specific to medical device product development using our guided compliance approach. This means your product development process is documented in a submission-ready format.
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:
- 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
Industry-Leading Risk Management
Compass provides medical device companies an advantage with it’s risk-first 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. Compass takes a templated approach to risk management, guiding the user with simple questions and using the answers to auto-populate risk analysis tables.
Compass guides you through the process of creating a:
- Risk Management Plan
- Preliminary Hazard Analysis
- Use Error Analysis
- Design FMEA
- Design Risk Analysis
Unlike other risk management tools, Compass not only manages individual risk data points, like hazards, hazardous situations, and harms, but it also manages the sequence of events that 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 as a whole that must be mitigated against.
In order 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.
Compass guides the development of best practice trace matrices with pre-configured templates – as design data is added, connections are automatically established. Once set up, when changes are made, objects are automatically promulgated across every connection in a trace. When a change has the potential to impact dependent relationships in the trace, those relationships can be easily identified for resolution. Compass trace matrices can be adapted to an organization’s SOPs and can be exported for reporting purposes.
Automated processes make it easy to apply quality best practices across the trace to ensure every change is accounted for and nothing falls through the cracks – a master map and single point of truth where all actions and their impacts across a product’s development lifecycle are recorded.
Regulatory Compliance is Not Optional
COMPASS SUPPORTS COMPLIANCE WITH MAJOR INDUSTRY STANDARDS AND REGULATIONS.
21 CFR 820.30
21 CFR Part 11
WANT TO LEARN MORE ABOUT HOW COMPASS SUPPORTS YOUR PRODUCT DEVELOPMENT COMPLIANCE NEEDS?
WHY DO LEADING MEDICAL DEVICE COMPANIES DEPEND COMPASS?
- A Unifying Solution – unifies your data into one system which enables you to focus on developing and not on maintaining or updating data and relationships.
- Data Integrity – provides a “single-source of truth” for every data item – if a requirement is changed in the product requirements document for example, it is automatically updated throughout.
- An Extension of Your Team – a customer-first approach to supporting and engaging with our customers. When you choose Cognition you are getting more than a SaaS solution for product development you are getting a team of developers, engineers, and industry-focused experts who are here to support and guide you beyond the sale.
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See How Compass Can Help You Get to Market Faster, With Complete Traceability.