Risk Management
Identify hazards and harm before they become a problem
Application Overview
It is mandated by law for companies to effectively identify all the potential risks, hazards, and harm that could occur while using a product before it enters the market. Risk Management in Aras Innovator helps risk managers identify, evaluate, analyze, assess, and mitigate potential product issues, hazards, and harm in a structured workflow.
From Identification, Assessment, and Management to Risk Reduction
The Risk Management application provides all functionalities you need to manage risk as part of the product development lifecycle. With a structured approach like the V-model product development process, you can:
- Identify hazards and risk factors that can potentially cause harm during the entire product lifecycle.
- Analyze and evaluate the risks associated with hazards.
- Determine ways to eliminate issues, and if impossible, determine a way to limit the risk of the product issue.
Improve Risk Management with Aras
- Unlock Your Risk Management Data
- Mastering Audit Preparation
Unlock Your Risk Management Data
Risk management in Aras Innovator brings quality, risk, and product data together in one place, enabling risk managers to make connections throughout. Connected data also provides for your data traceability matrix to be automatically generated, with no manual updates necessary. Unlock the data from your documents and design safety into your device. Start today by reading the white paper “Risk Management in Medical Devices.”
Mastering Audit Preparation
During an audit, it is essential to provide access to each specific version of your Design History File (DHF) and Device Master Record (DMR) linked to a specific revision of your product and to show a complete audit trail with content. Aras Innovator makes the process much more manageable with dedicated tools that help your medical device company with audit preparations.
