In an ever growing world of products that continuously affect our safety, safety becomes a critical aspect that must be addressed in product delivery. This can be achieved using industry best practice, and tools that will assure safety and risk were addressed before shipping the product.
Most recalls show that too little is done too late for managing risk, and that is why it is a challenge. Risk analysis is a must — such as failure mode and effects analysis (FMEA) for medical devices, or automotive safety integrity level (ASIL) in case your product integrates into the automotive industry. While risk analysis is important, it also complicates your product requirements. With FMEA, you need to prioritize risk and decide what to mitigate, eliminate, or accept. Complying with ASIL, you need to classify risk using ISO 26262.
Orcanos provides a fully integrated risk management system that allows you to easily manage your product risk and assure traceability for risk mitigation.
The Orcanos system enables the following:
- Manage and track requirements of all types (hardware, software etc.)
- Mitigate risk using FMEA analysis
- Create a full traceability matrix for compliance
- Support multiple types of mitigations, such as IFU, user manual, training etc.
- Manage impact of change on product safety
Ready to manage risk? Visit us at www.orcanos.com