Industry solutions
Solutions Overview
With our proven expertise in medical device software and hardware development, we deliver successful embedded system products. We assist clients in turning their concepts into market-ready products, adapting to rapidly evolving markets. Our services encompass engineering, hardware, and software solutions for the medical electronics industry, covering control, conversion, sensing, processing, storage, display, and information transfer for medical field systems or applications such as defibrillators, ventilators, and laser treatment devices among many others.
Software Development
We employ various development methodologies based on project type, client needs, and standards, while adhering to our internal quality management procedures. In the medical devices industry, we primarily utilize two development approaches: the waterfall methodology and agile methodology.
We offer complete BSP development services for medical devices that include infrastructure development as well as the required modularity for scalability and long-term maintenance. Our BSP solutions are of the highest standards in the industry, tailored to customer requirements.
Our BSP Development Services Include:
- BSP development for Linux, QNX, VxWorks, RTOS
- Bootloader development, secure boot, PKI infrastructure setup
- Bootloader integration and boot scheme development for normal operation, recovery, software updates etc.
- Boot time optimization
- Memory footprint optimization
- OS stacks configuration, networking, USB, video, RS-232
- Build system development
- Hardware tests and bring-up
- Device drivers development for peripherals and software stacks
- Startup code development
- Drivers backporting
Our team of embedded engineers has a rich experience with various microcontrollers, from single processors to multi-processors and digital signal processors. We specialize in optimizing, testing and debugging hardware prototypes and shorten the “time to market” for the designed products. Our middleware software brings unified interfaces scalable and transparent functionalities overcoming problems related to reuse and code portability.
Key Development Areas:
- BSP development for Linux, QNX, VxWorks, RTOS
- Bootloader development, secure boot, PKI infrastructure setup
- Bootloader integration and boot scheme development for normal operation, recovery, software updates etc.
- Boot time optimization
- Memory footprint optimization
- OS stacks configuration, networking, USB, video, RS-232
- Build system development
- Hardware tests and bring-up
- Device drivers development for peripherals and software stacks
- Startup code development
- Drivers backporting
We offer tailored embedded solutions for medical devices by using modern frameworks for domain specific applications, APIs for integration with other systems and libraries, simulators for quick prototyping, widgets, or display controls. All the User Interface development and integration services that we offer are meant to bring color, ease-of-use and aesthetical design to the integrated systems. Our solutions are cross-platform, with high-performance capabilities, integrating simple and user-friendly APIs, designed for multilingual support and highly flexible.
Key Development Areas:
- Graphical user interfaces (GUIs)
- Voice-controlled interfaces (VUIs)
- Gesture-based interfaces
Computer Vision
We offer tailored embedded solutions for medical devices by using modern frameworks for domain specific applications, APIs for integration with other systems and libraries, simulators for quick prototyping, widgets, or display controls. All the User Interface development and integration services that we offer are meant to bring color, ease of usage and aesthetical design to the integrated systems. Our solutions are cross-platform, with high-performance capabilities, integrating simple and user-friendly APIs, designed for multilingual support and highly flexible.
Key Development Areas:
- Deep learning-based methods using different networks, such as: R-CNN, HOG, SPP net etc.
- Data preprocessing and filtering
- Dimensionality reduction (PCA)
- Semi-automated data labeling and preparation for training
- Tooling for testing and validation of the object detectors
- Threshold based image segmentation
- Semantic Segmentation
- Clustering/feature Based Segmentation
- 3D Segmentation
- Geometry Calibration
- Mono cameras
- Intrinsic and extrinsic parameters calibration, pattern based and feature based calibration
- Online/dynamic camera calibration
- Stereo camera calibration
- Camera rig calibration for 360 deg panoramic image stitching, using feature-based calibration methods
- Feature based object tracking, e.g. KLT
- Optical flow-based object tracking
- 3D object tracking based on statistical models, e.g. Kalman filters/estimators (UKF, EKF, LKF), particle filters etc.
- Target modelling and simulation
- Measurement and dynamic models development
- Algorithms validation and testing
- Low level feature detections such as corners, edges, blobs SIFT
- Curvature detection based on the gradient of the detected edges
- Motion detection based on optical flow
- Image Acquisition
- Feature Detection and Description using ORB method
- Homography Matrix Estimation
- Image Transformation using Homography Matrix
- Blending Transformed Images
- Morphological Filtering
- Histogram Equalization
- Noise Removal
- Linear Contrast Adjustment
- Median Filtering
- Unsharp Mask Filtering
- Contrast-Limited Adaptive Histogram Equalization
- Decorrelation Stretch
2D image reconstruction:
- 2D image reconstruction from CT projected data
- ART-TV reconstruction
- Adaptive TpV regularization
3D image reconstruction from:
- 2D images from multiple views
- 3D points using analytical reconstruction methods and iterative reconstruction methods
safety, security and testing
Cybersecurity
Our security solutions are compliant with ISO 14971 and incorporate the following steps:
- Security Management – All security-related activities should be planned and documented
- Specification of Requirements – These must be defined in a similar vein to your software specifications
- Security by Design – The design process should be in compliance with the device and incorporate cybersecurity
- Implementation – Cybersecurity design should be implemented properly. You also need to ensure that any procedures on software releases are followed accordingly
- Verification and Validation Testing – Define these activities and tie them to the risk of your software, then performing validation testing
- Management Security – How you will handle any security issues if they do arise
- Update Management – Defining how you would assess any risks and roll out any updates
- Security Guidelines – Provide user documentation on how to operate the software with cybersecurity in mind
Safety
- ISO 13485: Safety and quality management systems
- ISO 14971: Application of risk management
- IEC 62366-1: Application of usability engineering
- IEC 60601: Safety and essential performance
Testing
- Unit and module testing
- KPI verification and validation
- Hardware in the loop (HIL) testing
- Module in the loop (MIL) testing
- Software in the loop (SIL) testing
Hardware Development
We develop hardware for medical devices from concept to creation. This includes the design of the electronic schematic, layout design, and design optimization. For every step of development process our team ensures that:
- The electronic components are placed and routed optimally
- The signal integrity, thermal, mechanical constraints are dealt with optimally
- Specific project and certification requirements are implemented and tested robustly
- The design is optimized for manufacturing and series production
To ensure a superior quality of the systems we design, our team develops the necessary environments for simulating the circuits so that the electrical, thermal, and mechanical parameters fall within the limits allowed by the client and legal requirements.
Our engineers also ensure that the circuits are manufactured according to project specifications and provide customers with the necessary assistance in communicating with the printed circuit board manufacturers, choosing the best suppliers that can produce the printed circuit boards according to the specifications of the design and within the budget of the customers.
PCB SCHEMATIC design
Our team of hardware engineers takes care of all aspects related to PCB schematic design, from the initial system concept up to the actual schematic design. We offer optimized schematic designs that are optimal and simulated thoroughly.
Key Development Areas:
- Complete schematic designs from initial concept design up to complete PCB schematic design and its corresponding documentation;
- Optimal schematic designs solutions through careful simulation of the designs and choosing the main components of the schematic;
- Perfect balance between budget and specific application needs.
PCB Layout design
Our team of engineers offers end-to-end solutions that accelerate the design of the most complex electronics and intelligent systems. By using specialized layout software, our team implements acording to the schematic the optimized layout for the PCB.
Key Development Areas:
- Optimized layout for the PCB based on the schematic design
- Single or multiple layers PCBs’
- Components’ placement optimization
- Routing that defines the optimal electrical connectivity
- Requirements for placement, signal, and thermal integrity consideration
PCB design optimization
Our team of expert hardware engineers optimizes the design of the PCBs’ by taking care of all aspects regarding component placement, spacing, clearances, thermal relief, and shape restraints. Our team of engineers debugs, inspects, and tests so that the PCB design is fully optimized for serial production.
Key Development Areas:
- Debugging, inspecting, and testing
- Fully optimized PCB design according to the customers’ requirements, as well as the number of layers required, the best suitable components, the quality, and the cost factor
- PCB designs completely optimized for serial production
testing, Standars and compliAnce
Hardware Compliance Services
- We determine and satisfy the device registration requirements
- We employ quality system management in accordance with ISO 13485 as part of the design plan
- We include any labelling requirements
- We ensure that the design incorporates materials that meet IPC 6011 requirements
- We design the device such that it is in compliance with FCC Title 47 for radiation emitting devices
- We ensure that the product meets the standards of IEC 60601 or IEC 61010 depending on its operating environment
Hardware Tests
- Electromagnetic Interference (EMI) Testing
- Electromagnetic Compatibility (EMC) Testing
- CE Certification
- RoHS Certification
Hardware Standards
- Good manufacturing practice (GMP)
- General requirements for the competence of testing and calibration laboratories as per ISO 17025 standard