Improve the visibility and traceability of your data and get ready for EU MDR
In a heavily regulated industry, it has never been more important to ensure that your medical device products meets industry standards.
That is why it is critical for medical device manufacturers to document that products are created using structured, repeatable and controlled processes to ensure quality and regulatory compliance.
Medical device manufacturers can benefit from a solution that enforce regulatory compliant manufacturing operations while enhancing the ability to define, schedule, execute and assure manufacture processes that optimize quality and efficiency.
Integrating regulatory workflows into your product engineering lifecycle allows you to transform compliance overhead into engineering intelligence. This eliminates the need for silos quality systems that deplete time, money and resources.
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.
Adding regulatory workflows to your engineering lifecycle can help you continuously improve and transform both products and engineering practices.
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.
It all starts with the requirements.
In order to ensure the safety and security of your customers, your products and services must meet industry standards. Medical Device PLM allows your organization to trace requirements throughout the product lifecycle. Unique change management notifications for CAD designers provide a link to requirements, allowing your teams to make the right decisions based on the most up-to-date product data.
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.
Without a complete, digital Bill of Material (BOM), teams across your organization will feel the sting of increased costs, decreased product quality, and delayed time to market. Medical Device PLM enables you to adopt a parts-centric approach to managing your BoM with a single source of truth to all product data across your organization. Experience true closed-loop lifecycle management from early concept through all iterations, design cycles, and stages until your product is fully released.
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.
The average engineer loses 25% of their time to data management. That’s time wasted searching for files, recreating data, updating systems and answering requests.
Medical Device PLM makes data management easy with a single view to the latest multi-CAD and product data. Securely share more consumable data with non-engineering colleagues through role-based, self-service applications and 3D visualization technology.
Now available in the Cloud, Medical Device PLM removes your burden of data administration and lets you get back to design.