Medical Devices

Software development in medical systems is influenced by the following trends.

• Better support from work processes
• Increasingly diverse types of therapy
• Simple network capabilities and comprehensive communication functions
• Increasing requirements for dependability, availability and maintainability.

Special challenges in developing software for medical systems include:

• Managing the growing range of functions and complexity while improving performance and quality
• Efficient version management and maintenance
• Complying with legal and regulatory requirements

iMED - A process model compliant with IEC 62304

The infoteam Medical Device Lifecycle Process Model (iMED) is based on the Microsoft Team Foundation Server and is suitable for developing and operating software as a standalone medical product or as a part of a medical product as described by Medical Device Directive (MDD) and compliant with standard IEC 62304 ISO14971 and others. Verifiably, transparently and efficiently.

Usability

Usability creates immediate added value for the user and reduces the risk of operating errors. User-friendly devices improve user acceptance and gain long-term preference when products are purchased. Interoperability among various devices is becoming more and more important in users’ everyday lives.

Naturally, it takes expert knowledge to develop applications that process larger amounts of data, and to process information for graphic representation on easily comprehensible, user-friendly interfaces. This knowledge must include current software technologies such as WPF, WCF, QT, SQL-Server and others. However, the true added value in the collaboration among our specialists can be seen in their deep understanding of the special demands of medical technology.

Device software

One of infoteam’s core competencies is developing software for precise, flexible control of medical devices. We provide support in developing new devices and in further development of existing systems. Together with you, we work out the design based on risk analysis and on aspects of operating safety. Read more about how infoteam can help you develop device software.

Verification / Validation / Testing

Verification and validation are one of the critical aspects of medical system approval. Further crucial factors in a development project’s success include creating an appropriate test concept to accompany development, as well as capable test automation. These have decisive influence on the whole product. infoteam has unique references in designing and implementing powerful testing concepts.

infoteam also offers a workshop on the features and benefits of iMED>>