Device Engineering and Industrialization
Design & Development for Manufacturing and Assembly
Valtronic provides device engineering expertise to design and develop manufacturable devices of the highest quality.
From Idea to a Manufacturable Product
Any brilliant idea for a new device or for the improvement of an existing one requires design and development expertise and experience to turn it into reality. Why? Because many challenges arise if you do not have the in-house expertise and capabilities to think ahead and include manufacturability in your project. Valtronic’s experienced and highly skilled engineering team provides the expertise and out-of-the-box thinking you need to help you design your device from scratch or to review the design of an existing device to reach the next level of innovation. From feasibility to customized solutions, we provide all the capabilities needed to design and develop a manufacturable high-quality device.
Device Engineering Teams
The highly qualified Valtronic engineering team has developed design, testing, and qualification processes for various and complex devices. As soon as they onboard a new project, they apply methodologies such as Design for Manufacturing and Assembly (DFMA), Design for Testing (DFT) and New Product Introduction (NPI) to make sure all critical functionalities of your product will be addressed. In addition, they work in close collaboration with Manufacturing and thus know all of the stringent constraints inherent to device of the highest quality. Also, they immediately perform a thorough BOM analysis together with our Supply team to ensure optimized supply throughout your product life cycle. And finally, they work from scratch with our team of quality experts to provide the documentation you need to meet all ISO 13485, MDR, and FDA requirements.
In-House Engineering Capabilities
Optimized Design in a regulated environmentOur multidisciplinary team embraces every project with a system approach. This holistic engineering practice coupled with 40 years’ experience in devices of the highest quality design for manufacturing (DFM) allow us to address complex and often technologically challenging products. |
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- Functional & value analysis, design to cost
- Documentation (Planning, Requirements, Architecture, Design and Traceability)
- V-Cycle VMP from URS/SRS to V&V reports
- Test strategy (Integration Testing, System Testing)
- Modeling, simulation
- Prototyping, feasibility, iterative development
- Optimization
- QMS – FDA 21 CFR part 820 & ISO 13485
- Risk Management – MD ISO 14971
- General Safety – IEC 60601-1, 21 CFR part 803
- Usability – IEC 62366-1 and IEC 60601-1-6
- Safety by design – IEC-61508
Optimized Design in a regulated environment
Our multidisciplinary team embraces every project with a system approach. This holistic engineering practice coupled with 40 years’ experience in device design for manufacturing (DFM) allow us to address complex and often technologically challenging products.
- Functional & value analysis, design to cost
- Documentation (Planning, Requirements, Architecture, Design and Traceability)
- V-Cycle VMP from URS/SRS to V&V reports
- Test strategy (Integration Testing, System Testing)
- Modeling, simulation
- Prototyping, feasibility, iterative development
- Optimization
- QMS – FDA 21 CFR part 820 & ISO 13485
- Risk Management – MD ISO 14971
- General Safety – IEC 60601-1, 21 CFR part 803
- Usability – IEC 62366-1 and IEC 60601-1-6
- Safety by design – IEC-61508
Complex electronics designed for excellenceThe trend for miniaturization requires high-density advanced packaging. This means challenging PCB layouts and knowledge about manufacturing with placement of ever smaller SMD components. Our team has the experience and expertise with multilayer PCB designs, high density SMT layouts, rigid, flex and flex-rigid boards and more. |
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- Power supply (AC/DC ; DC/DC)
- Communication (BLE, Wifi, USB, Serial, etc.)
- Microcontroller Unit (MCU) integration by co-development with software team
- Sensors (IR, temperature, humidity, proximity and more…)
- Actuators (Linear, DC, brushless motor, …)
- HMI (Screen, front panel, ..)
- Miniaturization design (layout for flip-chip, CoC, CoB, CFC, etc.)
- Mechanical constraint integration by co-development
- Design on rigid, flex and flex-rigid boards
- DfX : Design for Excellence
- IPC-2221, IPC-2222, IPC-2223, IPC-7351
- ISO 60601-1: General Safety for MD
- Pre-test for EMC / ESD compliance (ISO 60601-1-2)
- Electronics dFMEA
- Technology survey to ensure sourcing
- Proof of Concept / Rapid prototyping development
- Instructions & files for PCB Manufacturing & Assembly
Complex electronics designed for excellence
The trend for miniaturization requires high-density advanced packaging. This means challenging PCB layouts and knowledge about manufacturing with placement of ever smaller SMD components. Our team has the experience and expertise with multilayer PCB designs, high density SMT layouts, rigid, flex and flex-rigid boards and more.
- Power supply (AC/DC ; DC/DC)
- Communication (BLE, Wifi, USB, Serial, etc.)
- Microcontroller Unit (MCU) integration by co-development with software team
- Sensors (IR, temperature, humidity, proximity and more…)
- Actuators (Linear, DC, brushless motor, …)
- HMI (Screen, front panel, ..)
- Miniaturization design (layout for flip-chip, CoC, CoB, CFC, etc.)
- Mechanical constraint integration by co-development
- Design on rigid, flex and flex-rigid boards
- DfX : Design for Excellence
- IPC-2221, IPC-2222, IPC-2223, IPC-7351
- ISO 60601-1: General Safety for MD
- Pre-test for EMC / ESD compliance (ISO 60601-1-2)
- Electronics dFMEA
- Technology survey to ensure sourcing
- Proof of Concept / Rapid prototyping development
- Instructions & files for PCB Manufacturing & Assembly
Design and integration of complex medical box build assembliesOur experienced team has a proven track record in building complex mechanical and micromechanical assemblies for medical devices and equipment. Whatever the complexity, our team will design a manufacturable assembly that will reduce risks all across your project phases and thus help you improve your time to market. |
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- Mechanics & Micromechanics
- Microelectronics
- Implantable
- Encapsulable/embeddable
- Fluidics
- Actuators and sensors
- Design for Cleanliness & sterilization
- IEC 60601-1-9: Requirements for environmentally conscious design
- IEC 62366-1: Usability
- Mechanical dFMEA
- 5 axis CNC machining
- Proof of concepts (PoC), rapid iterations
- Milling and lathe
- 3D printing
- Sheet metal
- Technology survey to ensure sourcing
- Proof of concept / Rapid prototyping development
- Instructions & files for PCB Manufacturing & Assembly
Design and integration of complex medical box build assemblies
Our experienced team has a proven track record in building complex mechanical and micromechanical assemblies for medical devices and equipment. Whatever the complexity, our team will design a manufacturable assembly that will reduce risks all across your project phases and thus help you improve your time to market.
- Mechanics & Micromechanics
- Microelectronics
- Implantable
- Encapsulable/embeddable
- Fluidics
- Actuators and sensors
- Design for Cleanliness & sterilization
- IEC 60601-1-9: Requirements for environmentally conscious design
- IEC 62366-1: Usability
- Mechanical dFMEA
- 5 axis CNC machining
- Proof of concepts (PoC), rapid iterations
- Milling and lathe
- 3D printing
- Sheet metal
- Technology survey to ensure sourcing
- Proof of concept / Rapid prototyping development
- Instructions & files for PCB Manufacturing & Assembly
Safe and FDA/IEC compliant software design and integrationOur software engineering team will support you at every step of the medical device software development lifecycle. From design to integration, through to cybersecurity and a customized test strategy, you can rely on our team to develop a safe, effective, and IEC 62304 /IEC 82304-compliant medical device. |
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- Embedded (MCU & DSP, STM32, Nordic, TI, etc.), including GUI
- Desktop (Windows, Linux), including GUI
- Custom software tools (Qt, CVI Labwindows, etc.)
- Modularity, maintainability and robustness
- Communication (BLE, Wifi, USB, Serial, etc.)
- Power management, memory management, optimization, MCU and hardware self-tests.
- Connected devices
- Production data
- Statical Analysis
- Software Unit Testing
- Software Integration Testing
- Software System Testing
- IEC-62304 – Lifecycle requirements for medical device SW.
- IEC-82304 – Lifecycle requirements for health SW designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware.
- SW dFMEA
- Bare metal scheduling, real-time programming and RTOS (FreeRTOS, Zephyr, Keil, Wind River, Linux, etc.)
- Programming languages (C/C++, Assembler, Python, VHDL, etc.)
Safe and FDA/IEC compliant software design and integration
Our software engineering team will support you at every step of the medical device software development lifecycle. From design to integration, through to cybersecurity and a customized test strategy, you can rely on our team to develop a safe, effective, and IEC 62304 /IEC 82304-compliant medical device.
- Embedded (MCU & DSP, STM32, Nordic, TI, etc.), including GUI
- Desktop (Windows, Linux), including GUI
- Custom software tools (Qt, CVI Labwindows, etc.)
- Modularity, maintainability and robustness
- Communication (BLE, Wifi, USB, Serial, etc.)
- Power management, memory management, optimization, MCU and hardware self-tests.
- Connected devices
- Production data
- Statical Analysis
- Software Unit Testing
- Software Integration Testing
- Software System Testing
- IEC-62304 – Lifecycle requirements for medical device SW.
- IEC-82304 – Lifecycle requirements for health SW designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware.
- SW dFMEA
- Bare metal scheduling, real-time programming and RTOS (FreeRTOS, Zephyr, Keil, Wind River, Linux, etc.)
- Programming languages (C/C++, Assembler, Python, VHDL, etc.)