LET CG HELP INCREASE PREDICTABILITY FOR REGULATORY PRODUCT APPROVAL & PRODUCT LAUNCH
The velocity of change coupled with the complexity of new business models and medical device technologies may seem like insurmountable friction. CG minimizes the friction by enabling you to create and manage multi-disciplinary requirements (mechanical, electrical, chemical, software, labeling, etc.), risk management (Hazards Analysis, Use FMEA, Systems FMEA, Design FMEA, Cyber FMEA, Software Assessments, pFMEA, etc.), and Verification and Validation Testing (including sampling). Leveraging best-in-class digital thread capabilities, CG helps you visualize with deep granularity the traceability, impact analysis, test coverage, and many other types of information required to rapidly and more efficiently drive high product design quality.
WHITEPAPER
ISO 14971 | International Standard For Risk Management
ISO 14971 is the international standard for risk management, and it guides how to identify, assess, and control risks of an organization. It also provides a framework for managing risks and guidelines to carrying out risk assessment activities.
CG HELPS DRIVE EFFICIENCY AND ERROR PROOFING OF YOUR DESIGN CONTROL SYSTEM
CG’s consulting expertise coupled with industry-leading technology (Siemens Polarion) delivers the best fit solution for your Design Control. CG’s product development and risk management experts can concurrently help you streamline your Design Control and Risk Management business processes in a configuration that also enables you to maximize the value of the Polarion technology, leveraging concepts of reuse, digital thread traceability, and visualization.
Choosing CG for design control and risk management needs has been a game-changer for our organization. Their industry expertise and tailored solutions have elevated our product development lifecycle processes, ensuring compliance and mitigating risks seamlessly. CG’s unified approach to Design Control and Risk Management technology reduced friction by seamlessly integrating various requirements, and testing processes. Partnering with CG strategically impacted our product development journey.
– Risk and Compliance Director, Global Healthcare Leader
CG’s Approach to Risk Management
As regulators are very interested in understanding all aspects of device modifications during a submission review, CG’s holistic approach to Risk Management is a Regulator’s dream. Our business process approach coupled with the Polarion technology allows regulators to rapidly and visually understand the rhyme and reason for the modifications, the potential risks and mitigations, the test plans and test evidence, etc. In addition to improving design quality and reducing design review time, CG’s approach also provides a much more responsive capability for addressing field issue investigations, providing value to all stakeholders.
CG’s Integrated Technology Approach
R&D leaders worry about how their organizations will keep up with the velocity of change while improving productivity and increasing capacity. CG’s integrated Design Control and Risk Management technology approach minimizes the friction by integrating all types of requirements, risk management and testing, while leveraging the concept of reuse to higher design quality and efficiency across the entire organization. As a result, organizations
- Increase R&D capacity
- Automate for complete traceability and design granularity
- Realize transparent validation and verification coverage
- Integrate product cybersecurity as part of a holistic approach to Risk Management