Enea Embedded Technology - Enea Embedded Medical Platform

The Enea Embedded Medical Platform (EE-Med) is a scalable, multiprocessor software and services solution designed specifically for safety-critical and high-availability embedded medical devices, from low-end mass produced to feature-rich high-end devices.

EE-Med provides all of the safety certified engineering services and the software components needed to design medical devices, including a hard real-time operating system, secure wireless and wireline networking, embedded Graphical User Interface (GUI), fault tolerant database, and comprehensive development environment.

SAFETY-CRITICAL AND EMBEDDED MEDICAL DEVICE SOFTWARE SOLUTION

EE-Med was designed with careful thought as to the processes involved in bringing an embedded medical or safety critical device through the necessary steps to achieve FDA certification.

The inherent features built into this architecture ensure a simplified development process and a reliable and readily available end product. The foundation of EE-Med is the high-availability, fault-tolerant OSE™ real-time operating system.

OSE combines fast, deterministic, real-time response with memory protection facilities that enable medical OEMs to isolate safety- and life-critical level A functions.

OSE's secure partitioning guarantees that failures in non-critical services such as networking do not impair life-critical services such as dispensing medication or monitoring vital signs.

OSE's guaranteed resource availability enhances reliability by ensuring that critical Level A functions always have prompt access to necessary CPU and memory resources.

And OSE's built-in fault detection and response mechanisms enhance reliability by initiating fault analysis and recovery as soon as one of the processes it is supervising fails to respond.

In addition, OSE uses a direct message-passing model for asynchronous Inter-Process Communications (IPC) that makes it easy for developers to establish fast, reliable communication between securely partitioned applications.

Direct message passing provides an especially powerful paradigm for medical devices that employ multiple processors to provide redundancy, increase performance, and partition critical and non-critical functions.

Other key benefits that separate the EE-Med software architecture from other solutions on the market include:

• Efficiency and reliability
• Scalable
• Dynamic software loading
• Sophisticated system simulation
• Memory protection
• Storage reliability
• Development tool support
• Persistent database management
• Networking support and security
• Customizable Graphical User Interface

ENGINEERING AND MEDICAL CERTIFICATION SERVICES

One of the most challenging aspects of bringing a medical device to market is obtaining FDA certification for the end product. To ensure approval, FDA-approved design and development methodologies must be implemented from the beginning to the end of the project.

Enea's Professional Services Division offers comprehensive engineering and medical certification services for EE-Med. This can include an FDA-approved roadmap and development process, full code validation and verification, hardware design and development, and product certification.

With more than 500 person-years of experience, the EE-Med engineering group is available to guide a development team through all aspects of a project from board bring up through FDA certification for the final product.

And because each embedded medical device has different requirements, all medical engineering services are customized for each project and tailored to fit the scope of services needed by the customer. The EE-Med engineering services can be offered on a daily or annual basis, on-site or off-site, by one engineer, or by an entire project team. The level of services is fully customized according to customer requirements.

PROVEN SOLUTION

For over 16 years, the OSE RTOS has been deployed in hundreds of embedded medical devices and millions of embedded products worldwide. Originally developed for the telecommunications industry as a platform for delivering critical communications services, OSE has quickly become the preferred operating system for high-availability applications and distributed systems. Systems designers focusing on safety, reliability, scalability and simplicity are increasingly making OSE their platform of choice.