Medical device software development is an ever-evolving field within the medical device industry, and it is growing increasingly complex in design and functionality. This constant growth matches the growing need for enhanced patient care and therapies. Now more than ever before, you need a trusted partner who can guide you through each and every step of your medical device software development process.

Sterling Medical Devices is well equipped to step in at any stage within your development lifecycle to help you develop a safe, effective, and FDA/IEC 62304 compliant medical device product. Here at Sterling, we will work closely with you and your team to understand every aspect of your design, development, and testing needs to help ensure a quality Class I, II, and III medical device product.

We can help you with any step in the medical device software development process, including:

  • Full lifecycle development
  • Software verification and validation testing
  • Design History File (DHF) Remediation
  • Expert testimony
  • Independent medical systems verification/validation to support you submissions
  • Unit module testing and integration testing
  • FFPGA design and development
  • Algorithm development

Specializing in Medical Device Software Development since 1998

Sterling Medical Devices is ISO 13485 certified and we work with medical device companies throughout the entire software development lifecycle using state-of-the-art tools and equipment. Our team will help you to align your medical device software development efforts with FDA expectations and gain faster regulatory approvals. We can help you move toward your best practices, such as leveraging safety assurance case principles to clearly demonstrate the safety of your medical device product.

Sterling is ISO 13485 registered and compliant with the following standards:

  • IEC 62304 – The FDA recognized CE Mark requirement for medical device software development.
  • ISO 14971 – The standard for managing risk for medical devices.
  • IEC 60601 – A series of technical safety and effectiveness benchmarks for medical electrical equipment.

Risk-based approach to medical device software development

In today’s world, software is more critical to the operation of medical device products than ever before. In fact, if software in a medical device can be defined as an instrument, apparatus, implant, in vitro reagent, or accessory, then according to the FDA the software itself can be designated as a medical device.

While innovations in medical device software design gives rise to new medical device developments and breakthroughs, they also create new concerns about patient and user safety and overall device effectiveness. According to the FDA, most medical device recalls are related to software design failures, and when software as a medical device fails, patients and users are at risk.

A trusted partner like Sterling Medical Devices can help you address your software design challenges and help you streamline the process of having your medical device product reviewed by the FDA. Our team works with you to understand the intended use of your medical device software and all of the requirements that your software must meet in order to be considered a safe, secure, and compliant medical device product.

Dedicated and Experienced Team, Committed to Efficiency and Transparency

Our full-time team of engineers holds a wealth of experience and their focus is on ensuring the job is completed correctly the first time. We help you determine your software level of concern, ensure that your software is 100% safe, and that it meets all necessary standards to pass the required regulations.

Whether serving as your full-time development team or aiding your current team in any phase or area of need – from documentation and testing, to risk management and development – our staff keeps you up to date, well informed, and thoroughly involved in every part of the process. Our team champions efficiency throughout the software development process, leveraging best practices and tools to manage risk and stay on schedule.

You will feel safe knowing the Sterling Medical Devices team that you have come to rely on during the length of your project will be there for you to call on again, even after the project is finished.

To learn more about how our team can help you with medical device software development contact us or call 201.227.7569 ext.2

Mobile (App)

As time goes on, it becomes clearer and clearer that the market is heading in the direction of mobile medical app design. New developing technologies transform smartphones and tablets into healthcare tools, bringing in a new era of digital health.

Bringing any medical device to market is a complex process and the relative newness of mobile medicine (mHealth) could add further complications. Mobile device technologies have unique challenges that need to be understood to assist in the design and development process. If your mobile device application needs to work on Android and iPhone devices, choosing to work with Sterling Medical Devices will make all the difference.

Experts in Mobile Medical Devices

  • Full cycle approach to medical device app design and development
  • Experience in Android and iPhone mobile medical device projects
  • Medical device app development for iPhone
  • Medical device app development for Android
  • Design medical device applications for iPads
  • Mobile Medical Device Software/System verification and validation
  • Algorithm Development
  • Work on 50K, PMA and CE Class I, II, and III devices resulting in successful submissions
  • Get products to market quickly and cost efficiently
  • Utilize state-of-the-art tools and electronic test equipment
  • Completed independent verification/validation of medical systems to support your submissions
  • Proven track record of FDA/CE approvals

Maximizing Efficiency through Our Mobile Experience

Our team is highly experienced when it comes to working with the FDA and European regulatory bodies, and that experience includes mobile medical devices. Our engineering methodologies are optimized to keep expenses low and design times down. Our team at Sterling Medical Devices understands how to minimize the total duration of mobile medical device projects as a way to maximize your return on investment – all while keeping your bottom line costs at a minimum. Plus, our reverse engineers service allows our clients to quickly create prototypes and utilize prior work to generate all the necessary documentation required for regulatory approval – all without compromising quality.

Whether you are just starting out or need help applying the finishing touches, it is never too late to get us involved.

Why Sterling?

Since our founding in 1998, Sterling Medical Devices has demonstrated expertise in delivering medical devices and related services that are aligned with customer and regulatory requirements. We help customers, ranging from startups to Fortune 500 corporations, in all facets of Class I, II, and III electronics medical device design by minimizing risks, overcoming time and budget obstacles, and maximizing chances of a successful FDA & EU approval process by doing things right the first time.

Let Sterling Medical Devices show how to move your idea from concept to prototype to FDA/CE approval with a free customized analysis.

Cloud/Web

Cloud and web capabilities for medical devices are becoming seemingly common within today’s marketspace. These systems do more than collect and/or display sensor and patient data; they also have the capability to reach out wirelessly to the cloud for computation, directed alerts, and data storage. These new interconnected medical devices provide patients and healthcare providers with instant information. This creates an atmosphere in which important information for a patient’s medical device (i.e. an alert from an infusion pump, heart monitor, etc.) can be instantly transferred to a doctor or family member.

Sterling Medical Devices creates reliable, cloud-compatible devices, and through testing and regulatory processes Sterling is able to ensure that your device will function adequately according to its intended use and be safe for patients and users. Sterling has demonstrated expertise in delivering medical devices and related services that are aligned with customer and regulatory requirements since its founding in 1998. Choosing Sterling Medical Devices can help you address your software design challenges and help you through the process of having your medical device product reviewed by the FDA. Our team works with you to understand the intended use of your medical device software and all of the requirements that your software must meet in order to be considered a safe, secure, and compliant medical device product. We help customers, ranging from startups to Fortune 500 corporations, in all facets of Class I, II, and III electronics medical device design by minimizing risks, overcoming time and budget obstacles, and maximizing chances of a successful FDA & EU approval process by doing things right the first time.

Firmware

Embedded software design is a major step within the development process of many medical devices. It is necessary for these devices to have reliable, real-time operating system interfaces and controls for their subsystems. Our firmware experts at Sterling Medical Devices have the ability to concentrate on the implementation of the technological needs unique to your device. Our embedded software is designed specifically for your implementation, and Sterling Medical Devices can guarantee our medical device software development process to be transparent to our clients, and you will be in control of the direction that your medical device moves in.

Sterling Medical Devices, since its founding in 1998, has been consistently demonstrating our expertise within the field of delivering medical devices that abide to all customer and regulatory requirements. Sterling is the right choice for your medical device if you have a desire to work through current software design issues, as well as receive assistance through the FDA’s review process. Our team will work with you to understand your unique vision for your medical device, and help you understand all of the requirements and regulations that your software must meet to be deemed a compliant medical device. We help customers that are in the very beginning of their medical device development process, or that are just looking for help with a certain aspect of their device. It is never too late to get Sterling involved in your software development process to ensure that your device maximizes chances of a successful FDA & EU approval process.

IOT

The medical industry, as a whole, has slowly but surely began to enter the interconnected world of IoT. For example, electronic medical records have started their implementation nationwide, and patients now have the ability to obtain their records from online portals. However, the future of IoT in medicine lies directly in the field of medical devices. The world of IoT provides medical engineers with wireless sensor technology, remote and continuous monitoring, mobile connectivity, microscale actuation and motor tools, and 3D printing capabilities of living tissue. The field of Internet of Things for Medical Devices (IoT-MD) promotes the quick flow of information and enables easy access to the patient and the healthcare environment. It reduces the amount of clinical error and treatment costs through use of human predictive maintenance.

Sterling Medical Devices as a medical device development partners, has access to manufacturing resources that can produce technologically complex products with speed, precision, compliance and consistently high quality. As your partner within the process of medical device software development, we can help you meet all of you goals while staying within your budget and timeframe. Our team here at Sterling Medical Devices will help you produce a medical device that has a very good chance of successfully completing the FDA/CE approval process. We help customers ranging from startups to Fortune 500 corporations not matter where they are in their medical device’s lifecycle, and we maximize chances of a successful FDA & EU approval process by doing things right the first time.

Windows/Linux/RTOS

Operating systems are very important to the development and functionality of any medical device. The operating system is the software used to make sure that your medical device is able to perform all of its duties in a smooth and efficient manner. Four important ideas that software developers must keep in mind when working are safety, performance, economics, and functionality. Software developers must ensure, alongside the software being fit for the unique medical it is operating within, that the well-being of the patient (and the medical staff) is considered, that the embedded systems meet all of the necessary performance criteria, costs for consumers are controlled, and ultimately that the device provides the goal set of facilities to the user.

Sterling Medical Devices focuses the medical device software development process on the most important aspects of your device, such as usability and reliability. Sterling has nearly twenty years of industry experience, and knows that developing software that renders a high-quality user interface. Sterling can help you through the development process of your medical device and prove the consistency of its software and operating systems through testing and validation processes. No matter where your device is in its development lifecycle, it is never too late to get Sterling Medical Devices involved in the process.

Cybersecurity

Technological advancements are making today’s world increasingly mobile and our devices are becoming more connected than ever before. Although these developments have lots of benefits, the medical device industry looks at a constantly growing security risk. It is imperative that networked medical devices have strong cybersecurity features to protect the users and patients tied to each and every device. See our Medical Device Cybersecurity page to learn more about the FDA’s cybersecurity regulations for medical device manufacturers, and how Sterling Medical Devices can handle your medical device’s cybersecurity challenges.