Medical Devices
Enable regulatory compliance, reduce risk, achieve faster time to market.
Medical Device Leaders Solve Their Toughest Challenges with the Aras Platform
Aras Medical Device
From managing short innovation cycles, growing interdisciplinarity, high complexity of research and development processes, and ever-stricter regulatory requirements, medical device companies must overcome several challenges to stay ahead of the competition.
Aras Medical Device supports medical device companies from the first idea to market approval and re-certification through secure development processes. PLM offers automatic documentation traceability and quality management to manage compliance, design control, change management, and reporting. Take advantage of our deep industry knowledge of the medical device industry and proven practices from successful implementations with other medical device companies.
Design Control in Medical Device
- Part 1
- Part 2
- Part 3
Design control for product development
The goal for Design Control is to prove that product development meets the regulation requirements. But often, the typical industry practice is to design and print, then create the design and then print to paper and store that document in a binder. This practice makes it difficult to ensure that everything is aligned, all possible impacts are assessed and accounted for - and all deliverables are delivered at the correct time with the correct content.
Aras Medical Device targets these challenges by linking all deliverables to the the project plan, making sure everything is connected to the product data management. This allows the company to support product development throughout the entire chain from design input and output, to verification, and validation.
Real-time collaboration
Companies typically struggle with low visibility into other disciplines. This harms collaboration across departments.
Aras Medical Device ensures all disciplines and functions are working from the same requirements and systems model. This enables multiple engineering disciplines to collaborate with one another in design reviews and adhere to the same change management processes.
Connecting the dots
Aras Medical Device brings every discipline up to speed on change management and enables traceability for every action. 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.
Making Sense of the Digital Thread Chaos with PLM
In this Voice of the Customer report developed by Axendia, we explore the key benefits of implementing a Product Lifecycle Management (PLM) solution and how medical device companies are overcoming complex challenges in the life sciences industry. In this report, we will cover:
- Business objectives and goals
- Leveraging digital threads to support product lifecycle intelligence
- The value of PLM from business, regulatory, and technology perspectives
- Overcoming the barriers to PLM implementations
Connect Across Disciplines
Aras Medical Device is designed for interoperability, critical in the increasingly collaborative and networked world of healthcare 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.
- Works across systems and functional boundaries such as ERP and provides 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.
Based on our decades of systems and model-driven engineering experience, Aras Medical Device 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.
- 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 the digital thread to quickly respond to inquiries during regulatory reviews or sustaining incremental engineering changes.
With Aras Medical Device you will be able to manage all phases of the product lifecycle, especially the evolving product configuration and associated change process.
- This process can begin as early as the requirements and systems modeling stage, flowing through and eventually providing context for the industrial internet of things (IoT) data and supporting quality, manufacturing planning, and service documentation processes.
Medical Device Manufacturers Building with Aras
- Medical Devices & PLM
- Case Study
- Dräger
Medical Device Companies Benefit from PLM
The challenges medical device companies face in handling products from concept through launch to retirement are large and involve many processes across business units, extending to supply chain partners. Learn how product lifecycle management can help overcome these challenges and create greater efficiencies.
Carestream Health
Carestream Health, an international leader in the medical industry, manages projects and design history files with the Aras Innovator. See how they’ve successfully lowered costs, increased faster time to market, and achieved regulatory compliance.
Dräger and Digital Transformation
As part of its digital transformation efforts, Dräger, a leading international manufacturer of medical and security technology, replaced its Oracle Agile e6 installation with Aras Innovator.
Once our users open their mind to the fact that the tools delivered by Aras make their job so much easier, they adapt themselves quickly to the new system. With Aras Medical Device, we have a nice and clean solution that is extremely easy to use, and the feedback is that everything is easier to do now. The functionalities are much more useful now, so our users are very satisfied with working with the system.
Own the Lifecycle
Increasingly, product and services companies are seeking more information and control in the operational lifecycle of their products, including service and use in order to build more sustainable products delivering sustainable business value.
