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ISO 62304

is a standard for medical device software that provides guidelines for the software development process, including software design, development, testing, and maintenance. The standard provides a framework for managing the software development process to ensure that medical device software is safe, reliable, and effective.

The standard applies to software used in medical devices, including standalone software and software that is part of a medical device system. The standard provides guidance for the development of software in accordance with the risk management principles outlined in ISO 14971.

The ISO 62304 standard specifies the software development process through five main stages:

  1. Planning: This stage involves defining the software development process, including project management, risk management, and software configuration management.
  2. Requirements analysis: This stage involves analyzing and defining the requirements for the software.
  3. Design: This stage involves developing the software architecture and design based on the requirements defined in the previous stage.
  4. Implementation: This stage involves coding, testing, and integrating the software components.
  5. Verification: This stage involves testing the software to ensure that it meets the requirements and is safe and effective for use in a medical device.

The standard also provides guidance on documentation requirements, software maintenance, and software configuration management.

ISO 62304 is an important standard for medical device manufacturers, as it provides a framework for managing the software development process and ensuring that medical device software is safe, reliable, and effective. Compliance with the standard is often required by regulatory agencies, such as the U.S. Food and Drug Administration (FDA), for the approval of medical devices that incorporate software.

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V-model: software development model

The is a software development model that describes the development process from the initial requirements gathering phase through to the testing and maintenance of the finished software product. It is called the V-model because the development process is depicted as a V-shape, with the initial stages of the process at the top of the V and the testing and maintenance stages at the bottom.

The V-model is often used in software development projects where there are strict requirements for quality control and where it is essential to ensure that the software product is fully tested and meets all of the specified requirements. The model is designed to ensure that each stage of the development process is completed before moving on to the next stage, and that testing is carried out at each stage of the process.

The V-model is a structured approach to software development that involves the following stages:

  1. Requirements gathering: The requirements for the software product are gathered and documented.
  2. Design: The software design is created, based on the requirements gathered in the previous stage.
  3. Implementation: The software is implemented, based on the design created in the previous stage.
  4. Verification: Testing is carried out at each stage of the development process to ensure that the software meets the specified requirements.
  5. Maintenance: Once the software has been deployed, maintenance is carried out to ensure that it continues to function correctly.

The V-model is often compared to the traditional waterfall model of software development, as it involves a similar linear process of development. However, the V-model places a greater emphasis on testing and quality control, and each stage of the process is closely linked to the testing that is carried out at that stage.

In summary, the V-model is a software development model that is designed to ensure that each stage of the development process is completed before moving on to the next stage, and that testing is carried out at each stage of the process. It is often used in software development projects where there are strict requirements for quality control and where it is essential to ensure that the software product is fully tested and meets all of the specified requirements.

Imran Hashmi IBM ELM engineering lifecycle management

ibm.com/alm

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Digital Thread

A is a framework for connecting and integrating data throughout the entire product lifecycle, from design and development to manufacturing and maintenance. It involves the use of digital technologies, such as the Internet of Things (IoT), cloud computing, and artificial intelligence (AI), to capture, store, and analyze data at every stage of the product lifecycle.

The concept of a digital thread is based on the idea that a single, connected thread of data can be used to improve product quality, reduce costs, and enhance customer satisfaction. By connecting and integrating data across different stages of the product lifecycle, a digital thread can provide real-time insights and enable more efficient decision-making.

Some of the key benefits of a digital thread include:

  1. Improved collaboration: A digital thread can enable better collaboration between different teams and stakeholders involved in the product lifecycle, as it provides a single source of truth for product data.
  2. Increased visibility: By connecting and integrating data across different stages of the product lifecycle, a digital thread can provide real-time visibility into the status of a product, enabling better decision-making.
  3. Enhanced quality control: A digital thread can provide more comprehensive and accurate data for quality control purposes, allowing issues to be identified and addressed more quickly.
  4. Improved efficiency: By automating processes and providing real-time data, a digital thread can help to streamline processes and reduce waste, leading to greater efficiency and cost savings.

Overall, a digital thread is an important framework for connecting and integrating data throughout the product lifecycle, enabling better collaboration, increased visibility, and improved quality control. As digital technologies continue to evolve, the concept of a digital thread is likely to become even more important in the development of new products and services.

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SysML v2 Systems Modeling Language version 2

, or Systems Modeling Language version 2, is the next-generation version of SysML. SysML v2 is being developed by the Object Management Group (OMG), which is a standards organization that develops and maintains various software standards, including SysML.

The primary goal of SysML v2 is to address some of the limitations of the current version of SysML and to make it more scalable and adaptable to different modeling domains. SysML v2 will be a significant update to the language, with changes to the underlying semantics, syntax, and structure of the language.

Some of the key features of SysML v2 include:

  1. Model-driven engineering: SysML v2 will support model-driven engineering, which is a software engineering approach that emphasizes the use of models to design and develop software systems.
  2. Domain-specific languages: SysML v2 will support the creation of domain-specific languages (DSLs) that can be used to model specific aspects of a system. This will make it easier to develop models that are tailored to the needs of specific modeling domains.
  3. Improved scalability: SysML v2 will be designed to support larger and more complex systems than the current version of SysML. This will make it easier to model complex systems, such as cyber-physical systems and large-scale enterprise systems.
  4. Improved tool support: SysML v2 will be designed to work with modern modeling tools and environments, including cloud-based modeling tools and web-based collaboration tools.

Overall, SysML v2 represents a significant update to the Systems Modeling Language, with changes that are designed to make it more scalable, adaptable, and easier to use. As SysML v2 is still under development, it will be interesting to see how it evolves and how it is adopted by the modeling community.

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Siemens and IBM Collaborate to Accelerate Sustainable Product Development and Operations

Siemens Digital Industries Software and IBM (NYSE:IBM) today announced they are expanding their long-term partnership by collaborating to develop a combined software solution integrating their respective offerings for systems engineering, service lifecycle management and asset management.

Increasing competitive pressures, tight labor markets and growing environmental compliance objectives require organizations to adopt a more holistic management approach that spans the product and asset lifecycle. The companies will develop a combined software solution to help organizations optimize product lifecycles, and make it easier to improve traceability across processes, prototype and test concepts much earlier in development, and adopt more sustainable product designs. The goal is to help organizations speed innovation and time to market which can lead to improved quality and lowered costs.

The new combined SysML v1 standards-based suite of integrated engineering software is expected to support traceability and sustainable product development using a that links mechanical, electronics, electrical engineering and software design and implementation. It is intended to span the product lifecycle, from early design and manufacturing to operations, maintenance, update and end of life management. Initially, the companies are working to connect IBM Engineering System Design Rhapsody for systems engineering with solutions from the Siemens Xcelerator portfolio of software and services including Siemens' Teamcenter® software for Product Lifecycle Management (PLM) and Capital™ software for electrical/electronic (E/E) systems development and software implementation. The companies have also connected the IBM Maximo Application Suite for asset management with Siemens' Teamcenter software to support an integrated digital thread between service engineering, asset management and services execution. 

These integrations will focus on the effective reuse of processes and materials to allow traceability for sustainable product development. This can help companies to make informed decisions earlier in the design and engineering process to help drive improvements in cost, performance and sustainability. For example, companies can more quickly identify under-performing components or design elements that consume excessive amounts of power, or require maintenance or early replacement, and product innovation can be driven through an integrated digital thread that connects the physical and software assets back into product development. 

“A significant portion of product innovation and differentiation contains electrical, electronics and software components. Yet, manufacturing companies are struggling to bring new products to market on time, as the current tools, processes, and information to manage these components are siloed and disconnected,” said Kareem Yusuf Ph.D, Senior Vice President, Product Management and Growth, IBM Software. “To address this gap, IBM and Siemens are collaborating on a digital thread environment to integrate sustainability practices throughout the lifecycle of a product, from design, production, operation, maintenance and beyond. This connectivity will help enable quicker time to innovation and compliance preparedness, and overall improved product quality.”

are also collaborating to create a based solution with a migration path to help customers transition to next generation systems engineering.  SysML supports the specification, analysis, design, verification and validation of a broad range of systems and systems-of-systems. Service lifecycle management can assist in maximizing business value for product servitization by connecting service engineering to service maintenance to facilitate new collaborative processes between OEM and operators.

“Together, Siemens and IBM will deliver a simulation-driven systems and software engineering solution that is designed to cover the full operational lifecycle. This can empower our customers to innovate by helping to reduce product development costs, drive continuous improvement and create operational efficiencies across the extended enterprise throughout the product's operation lifecycle,” said Tony Hemmelgarn, President and Chief Executive Officer, Siemens Digital Industries Software. “We are developing this to help companies truly shift left by improving extensibility and reuse of systems models and associated data with standards-based solutions in an open ecosystem and to enable our customers to develop better products.”

Kamil Mrva, Chief Information Officer at ŠKODA Group and early adopter of the service lifecycle and asset management solution, said: “We are working very closely together with Siemens and IBM to help us to reach our sustainability goals, reduce total cost of ownership (TCO) of products for our customers and support our business transformation with an increased focus on services.”

Siemens will be supported by benefits through IBM's newly launched Partner Plus program and will offer the solution as part of the Siemens Xcelerator ecosystem.

Siemens Digital Industries Software helps organizations of all sizes digitally transform using software, hardware and services from the Siemens Xcelerator business platform. Siemens' software and the comprehensive digital twin enable companies to optimize their design, engineering and manufacturing processes to turn today's ideas into the sustainable products of the future. From chips to entire systems, from product to process, across all industries, Siemens Digital Industries Software is where today meets tomorrow.

IBM is a leading provider of global hybrid cloud and AI, and consulting expertise. It helps clients in more than 175 countries capitalize on insights from their data, streamline business processes, reduce costs and gain the competitive edge in their industries. For more information about IBM, please visit www.ibm.com. For more information about IBM Sustainability, please visit www.ibm.com/sustainability.  

Statements regarding IBM's future direction and intent are subject to change or withdrawal without notice, and represent goals and objectives only.


Siemens Digital Industries (DI) is an innovation leader in automation and digitalization. Closely collaborating with partners and customers, DI drives the digital transformation in the process and discrete industries. With its Digital Enterprise portfolio, DI provides companies of all sizes with an end-to-end set of products, solutions and services to integrate and digitalize the entire value chain. Optimized for the specific needs of each industry, DI's unique portfolio supports customers to achieve greater productivity and flexibility. DI is constantly adding innovations to its portfolio to integrate cutting-edge future technologies. Siemens Digital Industries has its global headquarters in Nuremberg, Germany, and has around 76,000 employees internationally.

Siemens AG (Berlin and Munich) is a technology company focused on industry, infrastructure, transport, and healthcare. From more resource-efficient factories, resilient supply chains, and smarter buildings and grids, to cleaner and more comfortable transportation as well as advanced healthcare, the company creates technology with purpose adding real value for customers. By combining the real and the digital worlds, Siemens empowers its customers to transform their industries and markets, helping them to transform the everyday for billions of people. Siemens also owns a majority stake in the publicly listed company Siemens Healthineers, a globally leading medical technology provider shaping the future of healthcare. In addition, Siemens holds a minority stake in Siemens Energy, a global leader in the transmission and generation of electrical power.

In fiscal 2022, which ended on September 30, 2022, the Siemens Group generated revenue of €72.0 billion and net income of €4.4 billion. As of September 30, 2022, the company had around 311,000 employees worldwide. Further information is available on the Internet at www.siemens.com.

This document contains statements related to Siemens future business and financial performance and future events or developments involving Siemens that may constitute forward-looking statements. These statements may be identified by words such as “expects,” “looks forward to,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” ….

Note: A list of relevant Siemens trademarks can be found here. Other trademarks belong to their respective owners

Contacts:

Siemens Digital Industries Software PR Team
Email: [email protected]

Hanna Smigala, IBM Media Relations
​Email: [email protected]