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
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.