MOONACHE, N.J. and LENEXA, Kan., November 13, 2024 – Vantage ALM, a Vantage MedTech Company has announced it is rebranding as Vantage ALM.
Vantage ALM helps engineering companies across the globe implement proven processes that govern successful product development, spanning Life Sciences, Automotive, Aerospace, Heavy Machinery and Industrial Automation. Their focus is on browser-based requirement management, application lifecycle management, and regulatory-compliant solutions that enable seamless collaboration across all stages of the product development life cycle.
This rebranding underscores the company’s expanded expertise and dedication to delivering end-to-end Application Lifecycle Management (ALM) solutions. By adopting the ALM identity, Vantage ALM reinforces its role as a strategic partner for industries that demand rigorous regulatory compliance and efficient product development. The new brand reflects a commitment to empowering clients with seamless management of every stage in the product lifecycle— from initial concept to final delivery—through integrated processes and solutions.
“The Vantage ALM name better reflects our mission to help customers gain complete visibility and control over their product development processes,” said Jim Bartel, CEO of Vantage ALM. “This evolution allows us to better communicate our value proposition as a trusted partner in product lifecycle management, helping clients overcome their most pressing challenges while driving innovation across industries.”
About Vantage ALM
Vantage ALM, a Vantage MedTech Company, delivers browser-based, regulatory-compliant solutions for application and requirements management, facilitating seamless collaboration across every phase of the product development life cycle. Whether you need assistance launching new systems or optimizing the performance of existing ones, our team is equipped to meet your needs. Formerly Vantage ALM, we specialize in empowering companies to implement efficient processes that drive successful product development and innovation.
About Vantage MedTech
Vantage MedTech provides comprehensive design and manufacturing services, supporting the advancement of medical technologies from concept through to product realization. Partnering with the world’s most innovative MedTech start-ups and large medical device companies, we offer feasibility support, product development and prototyping, clinical and commercial manufacturing, and after-market services to support every phase of the product life cycle. Our clients can leverage our proprietary Advantage Platforms®, accelerating product development timelines. Our manufacturing approach is structured to serve the changing needs of our clients, supporting small-quantity clinical or First-in-Human builds and can scale to accommodate full launch quantities. Vantage MedTech has facilities in Moonachie, New Jersey and Lenexa, Kansas. Additional information is available at available at VantageMedTech.com and on LinkedIn.
In early September, the International Organization for Standardization (ISO) released new ISO standards for medical devices: the ISO 10993-17:2023 (en) Biological Evaluation of Medical Devices-Part 17—Toxicological Risk Assessment of Medical Device Constituents. This document specifies requirements for a toxicological risk evaluation process of medical device constituents that are used within the biological evaluation process. It includes methods and criteria for identifying if exposure to a component poses any significant toxicological risk. According to ISO 10993-1, the biological evaluation of the finished medical devices may include the toxicological risk assessment.
The procedure outlined in this publication is applicable to data on chemical characterization of medical devices acquired in accordance with ISO 10993-18. A toxicological risk assessment of either the compositional information or analytical chemistry data is needed to determine if the components’ toxicological hazards are minimal or acceptable.
The definition of hazards in ISO 10993-17:2023 emphasizes the elements that potentially cause harm relevant to exposure situations. A trio of criteria play a role in the new protocol’s risk estimation:
The recent updates to ISO 10993-17:2023 have brought about significant changes to the document. To start, the previous title, “Biological Evaluation of Medical Devices-Part 17: Establishment of Allowable Limits for Leachable Substances,” has been replaced with one that better reflects its scope and purpose. The terminology has also been overhauled to include several new terms, including:
Other terms have been removed, including:
These terminology changes were implemented to bring more clarity and relevance of ISO 10993-17:2023 to medical device evaluation.
Additionally, the updated document offers more comprehensive guidance about:
Based on the recently updated FDA guidance, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process,” biocompatibility evaluations should be conducted within the framework of a risk management process. Once the risks have been identified, the sponsor should assess what information is already available regarding those risks and identify the knowledge gaps that remain in accordance with the additional biocompatibility standards. A plan should be developed to address the knowledge gaps either by biocompatibility testing or other evaluations that appropriately address the risks.
The guidance is intended for those who have some familiarity with medical devices, specifically toxicologists or other educated and skilled individuals who have the necessary education, work experience, and decision-making skills to apply it.For more information about the updated standards, how to complete a hazard analysis on your medical device, or help getting FDA pre-market approval, contact us here.
In September 2023, the FDA finalized its medical device cybersecurity guidance for premarket submissions. The updated document, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission,” details the information that must be submitted to the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER) for the premarket evaluation of products that involve cybersecurity risks. The guidance is applicable to any device or piece of software that can connect to the internet and is susceptible to cybersecurity threats, including but not limited to devices containing software or programmable logic.
Designed to keep patients safe and improve public health protection, the FDA cybersecurity requirements document includes pre-market guidance, as well as guidance related to monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices once they are on the market.
Specifically, the updated FDA cybersecurity guidance addresses the following submission types:
In the updated cybersecurity requirements, the FDA included recommendations related to comprehensive medical device cybersecurity risk management, continuous improvement throughout the total product life cycle, and incentivize changing marketed and distributed medical devices to reduce risk.
The FDA continues to make efforts to safeguard the safety and efficacy of medical devices at all points in their lifecycle in the face of possible cyber risks by collaborating with business and other federal government entities.
Cybersecurity is more important than ever in the medical device industry. As the FDA continues to make efforts to safeguard the safety and efficacy of medical devices to combat the growing attack surface, it is imperative that you maintain compliance across all points in your products’ lifecycle.
Here are some best practices to guide this process:
Though the above can seem daunting and overwhelming, it doesn’t have to be. With advanced expertise across the regulatory landscape, Sterling can help you complete the necessary steps to ensure your device meets all FDA cybersecurity requirements—all while keeping the design and development process moving forward without disruption.For more information about how to complete a medical device cybersecurity risk assessment, details about the FDA premarket submission cybersecurity guidelines, help ensuring your FDA premarket submission meets cybersecurity requirements, or guidance on how to protect your device from cyber threats, contact us here.
Your goal: To efficiently develop your product allowing for maximum success throughout the product lifecycle —whether it’s a cutting-edge medical device, an embedded system, an advanced aerospace design, or a new-generation automotive innovation.
Whatever your industry, this is no easy task. Product development always requires end-to-end visualization.
Product traceability is the process that makes this constant awareness possible.
Complexity demands comprehensive, continuous traceability in product development.
Why is traceability important? Product developers and managers are all dealing with ever-growing product complexity. In multifaceted environments, a product’s every element needs to be continuously monitored and tracked to ensure effective development and evolution. Companies using paper-based design processes risk falling behind their competitors, yet even those employing digital product traceability must ensure they meet high standards for comprehensiveness and full transparency.
State-of-the-art product traceability holistically verifies and helps manage the product development process, providing a 360° perspective on product development and implementation. To deliver optimum value, product traceability software has to clarify with forensic-level probability—exactly how the product progresses from its origins and initial development steps to its eventual use; and also, beyond that, through its continuing evolution.
Because advanced product traceability software links each step, process, and system based on pre-set rules and business logic, it can decipher even the most complex implementation. Evidence trails ensure that each action produces consistent and reproducible results. Every change is tracked and time-stamped. Subsystems work together, monitoring every process and identifying related impacts.
Consider, for example, embedded systems. They can pose particular design and development challenges because an overlooked system requirement could lead to painful redesign late in the process. Traceability matrix reflecting in-depth requirements traceability is critical for these systems because it is designed to ensure all the product’s requirements have been thoroughly addressed during each phase of the project. Yet even some automated product traceability tools for requirements traceability require manual backtracking, which can be more time-consuming than creating the requirement in the first place. When executed effectively, the possibility of scope holes in the developed system is virtually eliminated. Using a traceability matrix, requirements are internally consistent with each other across the board, and everything from the user story, business requirements, system requirements, test cases, design, risks and code changes, to bug reporting and fixing—all the way back to the user story—are completely and accurately managed.
Some companies continue to rely on lifecycle management tools that do not fully automate the entire traceability process, requiring users to manually update many aspects of the data. Others use paper based approach which is a manual and tedious process and often prone to human error.
On the other hand, product traceability, offered by Polarion ALM®, cultivates successful product development. It provides a level of efficiency that partially automated and manual matrices cannot. The industry-leading traceability software offering change management, real-time collaboration, regulatory compliance, and so much more, Polarion provides tracking capabilities that identify specific, disparate work items, define their various interrelationships, and deliver a complete view of the process hierarchy, forward and backward, at every time point.
These advanced capabilities, including live dashboard and detailed reports, ensure compliance with industry standards without relying on error-prone manual file updates. And Polarion delivers the most accurate visibility into supplier activity currently available, enabling a more streamlined decision making process.
A truly powerful traceability process can mean the difference between being on time and on budget—or being beset by inefficiencies, bottlenecks, and distractions. That’s why so many companies turn to Sterling to implement Polarion capabilities, not only for traceability in their development and manufacturing process, but also for the full Polarion product development ecosystem—including quality management, change management, requirements management, scalability, risk management, compliance, design, implementation, testing, and continuing support.
Sterling’s leadership in lifecycle management through Polarion ALM software means we will help you determine which specific processes are best for your needs; then we will implement the right solution every time.
Sterling provides expert Polarion consultants to help you document, track and monitor every aspect of your project, getting your product to market faster and more effectively, while propelling you directly toward your business goals. If you are seeking the highest levels of efficiency for product development, maintenance, and evolution through product traceability —whether your company is in a regulated industry or not—Sterling will make a measurable difference.
To maximize the benefits of Polarion, contact Sterling for more information. To learn more about proven processes to help you work efficiently, effectively, and take your business to the next level, download our masterclass on 6 Reasons to Maintain Traceability.
Expands Lifecycle Management and Live Traceability™ Expertise Offerings
Portland, Ore. and Moonachie, N.J., USA, Dec 7, 2022 — Jama Software®, the industry-leading requirements management and traceability solution provider, and Vantage ALM, an industry leader in engineering management problem-solving, have partnered to expand expertise and offerings across requirements management and Live Traceability™ solutions.
“Jama Software’s world-class consulting organization — that spans across multiple verticals, including medical device development — will be greatly complemented by this partnership with Vantage ALM,” said Tom Tseki, Chief Revenue Officer, Jama Software. “Vantage ALM expands on our already comprehensive services that drive measured improvements across product development processes that result in faster time to market and higher product quality.”
“At Vantage ALM, we have years of experience cultivating superior technical and lifecycle management know-how. We pride ourselves on our ability to anticipate problems before they become apparent to our clients,” said Dan Sterling, President, Chief Executive Officer, and Founder, Vantage ALM. “We are excited to add Jama Connect® to our arsenal of technology solutions, expanding our specialized expertise as we continue to take a customized approach to solving problems for our clients.”
Jama Connect, is the only platform that delivers Live Traceability across engineering disciplines through the entire product development process to reduce defects, delays, rework, and cost overruns. Vantage ALM‘s team has decades of combined experience consulting in highly regulated industries for a variety of medical device manufacturers. By partnering with Jama Software, Vantage ALM will collaborate and support lifecycle management services around configuration, training, and process development.
“We’re especially excited to leverage the expertise and experience of the Vantage ALM team with our Medical Device customers,” said Vincent Balgos, Director, Medical Solution, Jama Software. “They’ll be a great addition to our out-of-the-box solutions for medical device developers and provide specialty services, such as computer systems validation, and legacy tool data migration.”
Jama Software has consistently been listed as the leader for Requirements Management software tools by G2® for the fourth consecutive reporting period. By combining Vantage ALM’s customized solutions and seasoned expertise in lifecycle management technologies and Jama Software’s industry-leading requirements management and traceability offerings, Jama Software and Vantage ALM will continue to accelerate transformation to serve the needs of medical device developers.
Jama Software is focused on maximizing innovation success. Numerous firsts for humanity in fields such as fuel cells, electrification, space, autonomous vehicles, surgical robotics, and more all rely on Jama Connect® to minimize the risk of product failure, delays, cost overruns, compliance gaps, defects, and rework. Jama Connect uniquely creates Live Traceability™ through siloed development, test, and risk activities to provide end-to-end compliance, risk mitigation, and process improvement. Our rapidly growing customer base of more than 12.5 million users across 30 countries spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, financial services, and insurance industries. Click here for more information about Jama Connect services.
Vantage ALM helps engineering companies across the globe implement proven processes that govern the design and development of their engineered products, while leveraging software that tracks processes with greater visibility across the enterprise. Our team has decades of combined experience consulting in highly regulated industries for a variety of manufacturers—from small start-ups to large global organizations—and we’ve spent years cultivating unique skills and concentrated expertise in the business of engineering. We specialize in regulatory-compliant software programs that help customers track the project artifacts that they care about—across the entire project lifecycle.
Karrie Sundbom
Senior Director, Marketing, Jama Software
Anish Prabhu
Manager, Application Lifecycle Management, Vantage ALM
aprabhu@sterlingmedicaldevices.com
Cyber-physical Systems and PLM
Our world is getting smarter, but we don’t necessarily mean that our intelligence is expanding. Our pursuit of “smart” technology is increasing, in everything we do, use, and interact with. We want “smart” phones, watches, appliances, cars, homes, offices, and even entire cities – and the list grows each day. The term “smart” is a high-level view of concepts and technologies that combine to encompass what we think of as smart technologies, including cyber-physical systems (CPSs).
Cyber-physical systems are smart systems where physical and software components are deeply intertwined. In CPSs embedded software uses a network to control real-world interactions and transmit data. CPSs create a feedback loop that helps refine performance at the intersection of the physical and cyber elements. It comprises technologies like Internet of Things (IoT), machine learning, augmented reality (AR), artificial intelligence (AI), and cloud computing.
Cyber-physical systems and related technologies hold great potential for advancing the automotive, aerospace, medical device, and other industries that impact the global economy in everything from driverless cars and robotic surgery to emergency response and traffic management.
With great technology comes great complexity. The components of cyber-physical systems projects are intricately related and networked. Cyber-physical systems are by their nature more difficult to design, model, simulate, analyze, test, and bring to fruition. This is especially true when it comes to software development, which is a complex process in and of itself. The fusion of mechanical and software design and development needed for cyber-physical systems integration requires more advanced approaches than traditional product development methods. Agile product development, which relies on collaboration and flexibility, can be challenging to navigate with such complexities.
The more complex a cyber-physical system is, the more room there is for problems to occur, and the greater the importance of quality management. Because of their relationship to human safety, products in regulated industries require comprehensive, continuous verification, and validation, as well as physical systems and embedded software testing . And the more complicated a system is, the more vulnerabilities it could have. Even with similar names, CPSs and cybersecurity are different concepts, but they are linked. With how intricate they are, CPSs require more traditional approaches to ensure the cybersecurity of the software and physical components, but also more advanced tools like authentication, cryptography, and encryption.
In case you haven’t noticed, cyber-physical systems are both sophisticated and convoluted. So, they demand refined product lifecycle management (PLM) beyond simple physical or embedded system project management. CPSs bring different and additional artifacts, requirements, documents, multi-domain lifecycles, and multifaceted teams into a PLM that is already crowded.
The best way to overcome these challenges is through a systematic approach to PLM. This is most efficiently and effectively achieved using an application lifecycle management (ALM) tool, one that enhances requirements management, traceability, documentation, testing capabilities, collaboration, personalization, and customization. At Vantage ALM, we know how to tackle cyber-physical systems. We help engineering companies across the globe implement proven processes that govern the design and development of their high-tech, advanced engineered products, while leveraging software that tracks processes with greater visibility across the enterprise. We have decades of combined experience consulting in highly regulated industries for a variety of manufacturers—from small start-ups to large global organizations—and we’ve spent years cultivating unique skills and concentrated expertise in the business of engineering. We specialize in regulatory-compliant software ALMs that help customers track project artifacts across the entire project lifecycle. We offer aerospace, automotive, medical device, and embedded systems consulting services that can help boost your competitive edge in the market. Please contact us today.
Change management means different things to different people depending on the industry they work in. Thinking about it broadly, change management is the ability to track changes and implement them strategically. Change management in the medical device industry can be prompted by several scenarios – including updates to documents or document sets, products, and business processes as well as overall organizational change management.
Having a robust change management strategy is critical in the medical device industry. With the health and safety of patients hanging in the balance, the stakes are high, and change management enhances your ability to develop the best product you can. Change management in the medical device industry is also an expectation of regulatory bodies, both in the United States and abroad. When they evaluate whether the device is safe to be sold in their respective countries, they will require you to show evidence of your change management.
Best Practices for Change Management in the Medical Device Industry
Even though change management is an industry-standard, there are some key considerations to ensure it will ultimately improve the lifecycle of your medical device.
Have a change management plan. Having a plan in place is key to any endeavor, but especially in design, development, and change management in the medical device industry. Your plan should outline your goals, requirements, and how change management will be incorporated into each development phase, as well as your post-market activities. Your plan should also help you identify any change management gaps to avoid serious challenges later in the process. Every change you make may have ripple effects throughout your project and your plan should reflect that. Your plan should be recorded, reviewed, and shared with your leadership and change management team so they are all operating based on the same playbook.
Ensure traceability and version control. These are fundamental components of change management in the medical device industry. Traceability, or the ability of manufacturers to trace artifacts across an entire project, is crucial in compliance industries like the medical device industry. It includes tracking which artifacts are related and how, what changed, when it changed, by whom, and why. Version control, the process of locking in the specifications of a particular iteration of a product before making revisions, supports effective traceability and makes it easy to pull back changes if they are not successful.
Don’t neglect risk management. Risk management ensures that all identified risks have been evaluated and reduced to an acceptable level, or justified through risk-benefit analysis, throughout the life of the product. Just like change management in medical devices, regulatory bodies require it. Since changes to other development phases impact risk, risk management requires change management as well.
Choose the right tools. Like all product lifecycle management processes, change management in the medical device industry can be done manually. But it is much more efficient and effective to utilize intuitive tools that will automate processes and reduce errors. In today’s global medical device industry, a company’s ability to bring an innovative, cost-effective product to market quickly is dictated by how well they manage the processes that govern its design and development.
Following these best practices for change management in the medical device industry will help reduce product iterations, costs, and time to market. Vantage ALM has the expertise and knowledge of medical device product development lifecycle management tools to propel your change management to excellence. We offer tools where you can quickly and easily review and manage changes without having to hunt down related project artifacts and documents manually as well as mark links for impact analysis as things change. Our services can provide a framework for systematic change management that identifies every location where a specific change must be made and manages that change through approval and implementation. Please contact us today to get started.
An embedded system is the combined hardware and software that work together to perform a specific function for a device controlled electronically. Embedded systems are found in a variety of products, in everything from large industrial machines to the mobile phone you hold in your hand; from the car you drive to the equipment in your local hospital. As technologies advance, systems become more complex, with the potential to use millions of lines of code and thousands of parts in their design. More intricate complexities create more potential challenges in embedded system design.
No industry is exempt from challenges faced in designing an embedded system, and they are even more prevalent in regulated industries like the aerospace, automotive, and medical device industries where malfunctioning products can have serious consequences.
Here are some of the common challenges in embedded system design:
Collaboration: The more complex a system is, the higher the number of development teams and departments involved, and the greater their need for easy and effective collaboration. You know what they say about having too many cooks in the kitchen? Unlike the soup, the product will benefit from a multitude of collaborative minds, but it can also present several challenges in embedded system design. You must be able to identify where your colleagues are in their work to know how it impacts yours.
Communication: Good communication is key to collaboration. A missed or mixed message can create major setbacks and challenges in embedded system design.
Document and artifact tracking: Not being able to find required project artifacts in an easy and timely manner can cause costly delays to your company and customers and may even derail your ability to meet your deadlines. The capability to search and easily find a project artifact enhances your ability to collaborate effectively. If multiple teams are working with different versions of artifacts or documents, it is difficult to know if you can trust your data. Having a centralized location and management process for documentation is critical.
Traceability: Traceability is not a nice-to-have; it is a must have! It is essential for manufacturers to trace artifacts across an entire project, especially for regulated industries involving high risk and severe repercussions for defective products. If problems are identified during embedded software testing, traceability empowers the design and development teams to find out what and where things went wrong. Maintaining traceability and managing evolving requirements and interdependencies is a formidable task and can create challenges in embedded system design and development if not done properly.
Compatibility: With the complex nature of embedded systems, it is likely multiple teams with varied expertise and responsibilities across departments in a company, or perhaps even from different companies entirely, will work together to create the product. Each team may use different tools to perform and document their work, causing potential embedded software design issues or conflicts if the tools do not interface seamlessly with each other or if they utilize different languages and/or adhere to differing company standards. As you design, develop code, and test your hardware and software systems, it is necessary to consider how each subsystem integrates with the rest of the system in new and differentiated products. Losing focus on those considerations can result in challenges in embedded system design. Having the right tools, like a robust application lifecycle management (ALM) tool, can help to overcome many of these potential complications such as gaps in traceability, inconsistent version control, artifact duplication, and miscommunication between team members. Vantage ALM can help you identify what you need to avoid headaches in your embedded system design. Please reach out today to learn more about our embedded systems consulting and how it can help you.
When developing any product, the harder you look for problems before it goes to market, the better off you will be once it’s there. Software is designed to perform the same task, or set of tasks, over and over. Any unintended variation from that process is considered a defect. Managing and mitigating defects requires a strategic and systematic approach. Having a robust defect management process will help you catch defects early, reduce their impact, resolve the issues, prevent challenges moving forward, and improve your overall process.
The exact steps the defect management system goes through vary from product to product, but these are some critical elements every defect management workflow should include:
Prevention The best offense is a good defense, and it holds true in defect management. If developers ensure they have a thorough understanding of their guidelines and follow them, defects may be prevented before they even happen.
Baseline When a product reaches a milestone, it is considered baseline. Mapping out baseline can help you understand what your project is supposed to accomplish and identify where it is falling short, minimizing your need for defect management later.
Discovery This is where the defect is identified. It is much better for the project team to discover it than the customer.
Categorization Using defect categorization can help the product team prioritize managing each defect. It can be helpful to assign each with a category such as low (having only minimal impact on the device’s operation), medium (having some defects that are minor), high (the deviation affects a main function of the product), or critical (the defect must be corrected immediately at the risk of significant damage).
Resolution Of course, defect management is only effective if it includes resolving the problems. Resolution is where you assign a responsible party, schedule and map out the steps to fix, resolve the defect, and incorporate defect reporting and tracking once the resolution is completed.
Verification This is where the testing team verifies that the design team fixed the issue as outlined.
Closure If the defect has been resolved and verified, it is closed in the defect management process. If not, it is cycled back to the design team.
Reporting Defect reporting and tracking in software testing is when test managers compile the defect report and provide it to the management team for feedback. This allows the management team to give more support as needed and informs improvements needed in the process in the future.
Improvement It is always a good idea to look back at a process after it is completed. Armed with defect management data, teams can circle back to review previous defects and prevent them from happening in the future. If the defect repeats, the team already has the steps outlined in the system to fix it in shorter time.
Using Application Lifecycle Management (ALM) for Defect Status Flow
One way to ensure improvement in your defect management process is to use an ALM defect management tool. Monitoring your defect status in an ALM can help you identify and fix defects earlier, easier, and faster. But it is essential to choose an ALM tool that is right for you. Sterling’s consulting team is made up of experts who know ALM inside and out. We can help save you time and money with more streamlined product development timelines, smoother workflows, and exceptional defect management. Please contact us if our ALM software consulting services can help you.
What is Embedded System Software?
Embedded system software is a type of software that is used to operate electronic devices that are not traditional computers, or non-PC. It uses a microchip or another application that sits on top of the chip to control the specific functions for the device. Unlike a traditional computer, embedded software design is not transferable between devices and has fixed hardware capabilities and requirements. Embedded system software is made exclusively for a particular device depending on the device’s specified processing and memory restrictions.
What is the Difference Between Firmware vs. Embedded Software?
Even though the terms are often used interchangeably, there is a difference between embedded system software and firmware. Firmware is a type of embedded software, but not all embedded software is firmware. Embedded software controls a specific function of the overall device, while firmware is a minimalistic operating system instructing the control, monitoring, and data manipulation functions of the device. Firmware is usually developed along with the hardware for the product, then embedded software is developed to command the finished device or system. The added complexity of advancing embedded software presents new and different challenges from more basic firmware.
What is the Difference Between Embedded Systems vs. Embedded Software?
Even though their names are similar, embedded system software and what’s referred to as embedded systems are not the same thing. The embedded system is made of all the hardware in the product that comprises the structure for how the software is embedded into a system. This includes things like central processing units, flash memory devices, timers, power supply circuits, and serial communication ports. The hardware elements of the embedded system are determined early in the design process. Then the embedded system software is designed to control the device using that particular hardware configuration.
Examples of Devices Running Embedded Software
Embedded system software is an essential part of devices made with circuit boards and computer chips including consumer, industrial, automotive, aerospace, medical, commercial, telecom, and military technology. Embedded software systems help you every day with traffic control systems in traffic lights and timing and automation systems found in smart home products. They can also be found in security cameras with motion detectors, image processing systems in medical imaging equipment, and fly-by-wire control systems in aircraft.
While there are many uses of embedded system software, each device shares the same design features and characteristics, including:
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