AROBS Transilvania – custom software development company
MEDICAL DEVICES
Medical Devices
Medical devices companies all over the globe
confront considerable challenges in achieving
successful products and thriving market access. In
their efforts to develop the best possible products,
the global players in this sophisticated market will
always focus on product innovation and rigorous
safety measures. At the same time, the industry-specific
long product life cycles require the business to
keep investing in better, unique features.
Any partners of AROBS Engineering will benefit from our long-standing experience in addressing complex R&D projects with numerous technical and regulatory prerequisites and providing dependable testing systems and QA services.
Our teams provide software development services for designing and implementing complex, steadfast, and
standards-compliant platforms for medical devices.
The AROBS Engineering team has successfully developed many life-saving medical devices, including life-critical infusion pumps, robotic surgery solutions, and cancer detection systems. Their extensive experience makes the team well-equipped to handle complex projects and deliver solutions that meet industry standards. Learn more about our expertise in developing medical software and devices.
// Empowering Healthcare Through Technology. The Path to Secure and Efficient Processes
Medical Technology Whitepaper V 2.0 2024
Medical devices elevate patient care to new standards with minimal errors and maximum accuracy. In this whitepaper, you can discover medical devices’ role in healthcare processes, how they contribute to smart hospital development, and the relevance of security and device certification.
Mobile devices for health monitoring, wearable devices, implantable medical devices, and stationary and assistive medical devices such as infusion pumps are only a few examples that empower research and treatment evolution. These devices are redefining healthcare by offering real-time insights into patient health, enabling efficient data exchange and personalized, data-driven medical interventions.
Our achievements exemplify our commitment to medical innovation, from developing a scalable infrastructure for controlling and monitoring infusion pumps to successfully conducting an R&D project focused on cancer detection. AROBS Engineering specialists ensure that our solutions meet rigorous standards, facilitating the processes of entering new markets. Download the whitepaper and get inspired to shape the future of healthcare together!
Secured Software Development for Medical Devices
In our embedded software solutions for medical devices, safety is paramount. Our proactive team integrates security measures throughout development, ensuring solutions are standard-compliant and certified. Expertise in testing and validation guarantees the reliability of our solutions. We foster a culture of security awareness and stay ahead of threats through continuous improvement, including workshops on the latest standards like ISO 27001:2022. Emphasizing principles, we follow industry guidelines, standards, and regulations, safeguarding innovation in the medical device landscape, such as HIPAA and dedicated medical standards like ISO 13485 if needed.
References
AROBS Engineering has accelerated the development of various medical devices. Some of the most important projects include life-critical infusion pumps, robotic surgery, and cancer detection solutions.
Our teams specialize in creating embedded software platforms and solutions for high-tech, connected medical devices that
enhance healthcare capabilities and patient medical treatments by leveraging state-of-art technologies like Artificial Intelligence
(AI), Augmented Reality (AR), Internet of Things (IoT), and wearables.
The High-Performance Infusion Pumps project
In order to increase the performance of its life-critical infusion pumps family of devices, our partner needed a complete redesign
of the embedded software real time operating solution and middleware, in order to obtain a new system that needed to be
more performant and scalable, – capable of regulating and monitoring the pumps faster and easier.
The Robotic Surgery project
A renowned global medical industry company required a new software platform for a cataract surgery system. AROBS Engineering delivered a high-performance platform, commercial support, and insured customization and optimization for the
new platform.
Medical Industry Expertise
In addition to regulatory requirements, medical devices of today must also fulfill the patients’ necessities, along with those of the healthcare professionals and other medical services providers. The complex process of certifying software to comply with medical standards involves reviewing the software design, coding, validation, and verification.
Our teams know how to meet rigorous prerequisites for quality, standards fulfillment, along with performance criteria. Our experts bring substantial value to the medical device market. Performing excellent services on various projects for international leading medical device vendors, our specialists have also gathered a deep knowledge of the healthcare industry and developed a genuine partnership with pivotal players.
Linux & Real-time Operating Systems
Linux & RTOS Development & Porting
• Networking and Communication Engineering
• Middleware and Application Development,
• Drivers & Board Support Package (BSP)
• Kernel
Standards and Certifications
• Class II and III Device w/Agile
• Software Architecture Audit and Analysis
• Compliance Guidance & Medical Standards (e.g., MDD, FDA 510(k), IEC 62304)
• Test-driven Development
Testing and Validation
• Testing & Validation, Customized/Automated Testing Frameworks for Class II and III Software & Devices
• Test Script Development
• Functional, Performance, Unit, and System Testing and Validation
Embedded Software and Operating System experts
AROBS Engineering sustains its partners in all software development steps- from requirement analysis and specifications, through design and development, to validation, testing, and, of course, quality assurance. We invite you to leverage AROBS Engineering’s embedded software expertise to add brilliance, performance, and connectivity to your top-notch medical devices.