Improve the visibility and traceability of your data and get ready for EU MDR
The success of a medical device company is driven by its ability to bring innovative products to market faster whilst controlling and reducing costs.
Introducing new medical devices to market is always complex, but the administrative burden can be streamlined by having a design control software that can fully support the design process.
Enable your medical device company to become data-driven and document smart by powering your design process across engineering teams with increased efficiency, speed and clarity to produce safe, high quality device designs.
Design Control is our holistic solution for integrating requirements, risk management, test planning, execution and design output management, including Design History Files (DHF) and Device Master Records (DMR).
Medical Device PLM is designed for interoperability, critical in the increasingly collaborative and networked world of health care systems. Our solution allows you to deliver value in multi-tiered health care networks, while avoiding the disruption, risk and cost of a “rip-and-replace” approach.
Medical Device PLM helps organizations avoid overlooking common problems by guiding the tie off all risks and requirements, at all levels of detail, across all disciplines.
Our solution enables you to respond to issues and resultant changes, managing complexity at each phase of the development process with agility, efficiency, speed and accuracy.
Medical Device PLM In Depth:
Medical device product development is a highly integrated and regulated process. Implementation of solution-based requirements tracking requires attention to a variety of nuanced topics.
Medical Device PLM is designed for interoperability, critical in the increasingly collaborative and networked world of health care systems. Our solution allows you to deliver value in multi-tiered networks, while avoiding the disruption, risk and cost of a “rip-and-replace” approach.
Medical Device PLM:
- Works across systems and functional boundaries such as ERP and provide access to mechanical and electronic designs, software, requirements, technical documentation, process plans and quality documents.
- Leverage and extends your existing investments in ERP, PLM, and MES through application mashups.
- Rapidly prototype and deploy medical engineering applications that monitor, manage and control connected devices.
- Engineers independent and secure connectivity between devices.
- Manages devices and sensors.
- Collects and analyzes data from connected devices.
Based on our decades of systems and model-driven engineering experience, Medical Device PLM ensures all disciplines and functions are working from the same requirements and systems model. It enables the multidisciplinary development of devices that are systems of systems – integrating hardware, electronics, software and formulated components.
Medical Device PLM:
- Allows hardware and software deliverables to be structured in the same composite Bill of Materials (BoM), ensuring accuracy at critical hand-offs like Engineering to Manufacturing.
- Enables multiple engineering disciplines to collaborate with one another in design reviews and adhere to the same change management processes.
- Enables traceability. It means anyone connected to the platform can select a part and instantly view the related CAD model, requirements, change history, manufacturing execution data and in-service field data.
- Supports devices throughout the entire lifecycle by re-using data and connecting it via digital threads to quickly respond to inquiries during regulatory reviews or sustaining incremental engineering changes.
Avoid the risk by leveraging and enforcing best practices for product development teams. With Medical Device PLM you will be able to manage all phases of the product lifecycle, especially the evolving product configuration and associated changes process.
This process can begin as early as the requirements and systems modelling stage, flowing through and eventually providing context for industrial internet of things (IoT) data and supporting quality, manufacturing planning and service documentation processes.