Software Development and Engineering for Medical Devices
Developing Safe and Compliant Medical Device Software
Technology has forever changed the face of medical devices and hospital systems worldwide. When patients visit a hospital, the myriad technologies involved in providing their safe and effective care are almost too numerous to count.
Whether it’s the enterprise system the hospital uses to manage operations, the medical devices which affect the patients, or the secure network which connects everything together – the patient is trusting everything was built per FDA and international guidelines and software development and engineering best practices.
Advantu is well equipped to step in at any stage within your development lifecycle to help you deliver a safe, reliable and fully compliant medical device product.
How do we build successful connected care products? By making complex systems simple, elegant and compliant.
We’ve observed, during targeted gap analysis of (medical device company) quality and engineering processes, that most companies deliver compliant products…but their QMS programs are often incomplete, inadequate, or aren’t managed and executed per the “INTENT” of regulatory guidelines.
Advantu ensures your software development project meets or exceeds all FDA and international requirements from start through product release to the end of On-Market Support, for all your Class I, II and III regulated devices.
- Do you have a software project falling behind schedule?
- Did you lose a critical member of your engineering or quality team?
- Does your engineering team need support for maintenance activities – so they can focus on enhancements and new products?
- Are you concerned with compliance for your QMS processes and procedures?
We can help you with any step in the software development process, including:
- Quality Management System (QMS) “compliance to the intent”
- Full life software cycle development management and or mentoring activities
- Software verification & validation
- Unit module testing
- Integration testing
- FFPGA design & development
- Algorithm development
- Design history file (DHF) creation/remediation
- On-Market support
Specializing in Medical Device Software since 2014
Advantu works with medical device companies throughout their entire software development lifecycle using state-of-the-art tools, equipment and common-sense procedures/processes. Our team will help you align your medical device software development efforts exceeding compliance expectations and gaining faster regulatory approvals. We can help you move towards best practices mentoring your team as we go – in order to ensure your ongoing process improvement program is not only compliant but that your “Cost of Quality” adds to your bottom line, not deducting from it.
Our experience shows that software teams who engage with quality focused engineering at the beginning of a medical device project, enjoy a higher degree of success throughout the product life. This includes reduced time-to-market plus higher product quality, due to utilizing best practices across the cross-functional teams.
Additionally, there are no ‘last minute’ delays due to non-compliance with QMS documentation or processes – we begin every project with FDA and international compliant processes & documentation, in order to ensure success.
If you are mid-project and have concerns about product quality, delivery dates or compliance, then it’s time for a quick external review call. The earlier you address your concerns, the better off you’ll be, because… this is what we do. We help teams overcome compliance and engineering challenges in order to successfully reach their product goals.
When your clients and regulatory bodies are happy – you are happy.
Advantu’s Risk-Based Approach to Software Development and Engineering
Due to the critical nature of our Industry, patient-safety always guides our decision-making process for software engineering projects. By utilizing a risk-based approach, we stay ahead of any product quality or user needs challenges by identifying all the risks in the product, system, and implementation – so our clients and their end users don’t experience any unexpected and often costly surprises.
We have to think (and plan) multiple steps ahead, because the risks are incredibly high if anything is missed – patients are trusting that we are doing our jobs thoroughly, utilizing industry best practices and we’re compliant to the letter.
Dedicated and Experienced Team, Committed to Best Practices Results
Our team of engineers holds a wealth of experience and their focus is on ensuring your project is completed correctly the first time. They’ve all spent years, many of them decades, working in the medical device industry – and we bring all of that experience to your project. You and your customers benefit!
Bringing any medical device to market is a complex process, and the relative newness of mobile medicine could add further complications. Mobile device technologies have unique challenges that need to be understood – if your mobile device application needs to work on iPhone and Android devices – Advantu’s support will make all the difference for your success.
Cloud and web capabilities for medical devices are being utilized across the marketspace at an ever-increasing pace. These systems not only 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 healthcare providers and patients with instant information. This creates an atmosphere in which important information for a patient’s medical device (such as an alert from heart monitor, infusion pump, etc.) can be instantly transferred to care providers.
Sophisticated hospital systems are utilized to run large operations, performing a myriad of tasks from monitoring infusion data for ICU patients, to collecting the same data for billing, and ensuring all systems & devices throughout the network are operating properly and safely.
Often there are unknown interconnected systems at work within the hospital, from a large number of vendors, and they all need to integrate seamlessly for world class operation and patient safety. Any breakdown with the system, whether it’s connectivity, user interaction or system performance – can be catastrophic for the patients receiving treatment at that facility.
We understand the critical care being provided and the importance of 100% operational stability, compatibility and product quality in this environment. Your customers expect nothing less than complete product reliability.
Embedded software design is a critical step within the development process of most medical devices – it’s necessary for these devices to have reliable, real-time operating system interfaces and controls for their subsystems.
Our firmware experts at Advantu have the ability to concentrate on the implementation of the technological needs unique to your device. Because this is your project, our software development process will be completely transparent to you – our client – so you can enjoy the confidence your device will be built according to your wishes.
We believe in the “no surprise” policy; every project is planned, executed and delivered reliably and predictably – with your customers enjoying the highest level of product usability and reliability.
Operating systems are very important to the development and functionality of any medical device. It’s the software necessary to ensure your medical device is able to perform all of its duties in a smooth and efficient manner. Four key areas that software developers need to keep in mind are functionality, economics, safety and performance. When developing software for a medical device, we believe it’s crucial that compliance and SDLC best practices are followed to the letter – in order to ensure maximum patient safety is included with every product delivered.
It’s only through completely thorough design, development and consistent risk-based development and testing of your medical device software and operating system(s) – that your medical device will provide solid performance in the most severe environments, and keep every patient safe, no matter what.
Technological advancements are making today’s world increasingly mobile and our devices are becoming more connected than ever before. Although these developments have numerous benefits, the medical device industry sees 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.
Advantu has partnered with a heavily experienced team of Cybersecurity experts – to ensure there are no surprises down the road, by focusing on this issue from project start. We make sure your devices and data are safe from any nefarious outside entity attempting bad things. It’s our Promise.
Ongoing software maintenance is as important as the launch. DevOps integration, and attentive patch and new feature releases are the lifeblood of effective product lifecycle management. In collaboration with your IT operations team, we provide continuous development support for mobile and web-based systems, device and systems interoperability and API interactivity to help you maintain a stable classified system.
Risk Assessment, Mitigation and Residual
Throughout Design Input, Design Output and On-Market Surveillance Advantu employs risk activities applying ISO 14971 and IEC 62304 concepts and guidance to identify both user, product and process risks, planned mitigations and residual risks.
After product release, where contracted, Advantu will provide support management – ongoing problem and change management review and engineering support for the Production application code base and environment.
Advantu operates in the Tier 3 support level with review-level interaction at the lower tiers, as necessary.
Support management services are organized into Support streams. The streams are tiered packages of system maintenance activities covered under contract.
Each corresponds with an Advantu staffing module and minimum production period required to fulfill it.
Call Judy today & ask how we can support your R&D Team with a dedicated Engineering solution – let’s get this turned around in your favor!
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