Experts in the Design and Production of Electromedical Devices.<\/h1><\/div>We follow every stage of the life cycle of Medical Devices according to EU Regulation 2017\/745 and the harmonized technical standards of electromedical systems.<\/p>\n<\/div><\/div><\/div><\/div><\/div>
![](\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27800%27%20height%3D%27834%27%20viewBox%3D%270%200%20800%20834%27%3E%3Crect%20width%3D%27800%27%20height%3D%27834%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\")
<\/div><\/div>Medical Devices<\/h2><\/div>The creation of an Electromedical Device is a multifaceted process that combines the needs of medical practice with safeguarding the health and safety of Patients and Operators.<\/p>\n
For this reason, the lifecycle of Medical Devices is strictly regulated and must be competently followed as early as the planning stage.<\/p>\n
Technological advances must be supported by precise scientific evidence and systematic risk-benefit analysis, which go far beyond simple product engineering.<\/p>\n
We support our clients from the early planning stages, collaborating with medical personnel, consultants in specialized fields and Notified Bodies.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
![\"Studio](\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271398%27%20height%3D%27845%27%20viewBox%3D%270%200%201398%20845%27%3E%3Crect%20width%3D%271398%27%20height%3D%27845%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\")
<\/div><\/div>Electromedical Design<\/h2><\/div>We design the components of each electromedical system by collaborating with customers and medical personnel in defining the requirements.<\/p>\n
Whether it is the structural or design elements, the automation and electronic parts, or the software functionality, we carefully develop each element with expertise and attention to safety.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
![](\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27918%27%20height%3D%27709%27%20viewBox%3D%270%200%20918%20709%27%3E%3Crect%20width%3D%27918%27%20height%3D%27709%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\")
<\/div><\/div>Medical Software Development<\/h2><\/div>Medical Device software follows a specific scheme of planning, drafting, verification and documentation, adjusted for the level of risk in case of error, according to EN 62304 (Medical Software Lifecycle).<\/p>\n
We can structure mission-critical software for each of the three classes defined by the standard (A, B, C). Through meticulous planning, we can develop software involved in high-risk processes for Patients and Operators. <\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
![](\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27500%27%20height%3D%27390%27%20viewBox%3D%270%200%20500%20390%27%3E%3Crect%20width%3D%27500%27%20height%3D%27390%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\")
<\/div><\/div>Human-Machine Interfaces<\/h2><\/div>We develop interaction systems of varying complexity and Human-Machine Interfaces via touchscreen displays by leveraging our expertise in the embedded domain.<\/p>\n
We realize simple operator interfaces controlled directly by microcontrollers and complex projects by leveraging frameworks including JavaFX and QT\u00ae in the Linux\u00ae environment.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
![](\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27800%27%20height%3D%27450%27%20viewBox%3D%270%200%20800%20450%27%3E%3Crect%20width%3D%27800%27%20height%3D%27450%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\")
<\/div><\/div>Compliance Assistance<\/h2><\/div>The marketing of most of the Medical Devices we develop requires the involvement of a Notified Body for verification of type conformity (the product conforms to design specifications) and of the quality of production.<\/p>\n
We produce all or part of the technical dossiers, complete with Essential Requirements, Risk Analysis, Clinical Analysis, Usability Analysis, Software documentation, Validation, test reports from Accredited Laboratories, Follow-up procedures.<\/p>\n
We support our clients by interacting with the Notified Bodies that perform the analysis<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
![\"Assemblaggio](\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271200%27%20height%3D%27800%27%20viewBox%3D%270%200%201200%20800%27%3E%3Crect%20width%3D%271200%27%20height%3D%27800%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\")
<\/div><\/div>Electromedical production<\/h2><\/div>Our Quality Management System is ISO 13485 certified for the production of Electromedical Devices. We strictly follow internal procedures and production documentation to ensure compliance with the approved type. <\/p>\n
We fully manage the traceability of critical components at the time of purchase and at all stages of processing.<\/p>\n
We carry out testing, safety testing and end-of-line testing on each product.<\/p>\n
We follow production through to labeling and packaging.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
We follow every stage of the life cycle of Medical Devices according to EU Regulation 2017\/745 and the harmonized technical standards of electromedical systems.<\/p>\n<\/div><\/div><\/div><\/div><\/div>
Medical Devices<\/h2><\/div>The creation of an Electromedical Device is a multifaceted process that combines the needs of medical practice with safeguarding the health and safety of Patients and Operators.<\/p>\n
For this reason, the lifecycle of Medical Devices is strictly regulated and must be competently followed as early as the planning stage.<\/p>\n
Technological advances must be supported by precise scientific evidence and systematic risk-benefit analysis, which go far beyond simple product engineering.<\/p>\n
We support our clients from the early planning stages, collaborating with medical personnel, consultants in specialized fields and Notified Bodies.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div>Electromedical Design<\/h2><\/div>We design the components of each electromedical system by collaborating with customers and medical personnel in defining the requirements.<\/p>\n
Whether it is the structural or design elements, the automation and electronic parts, or the software functionality, we carefully develop each element with expertise and attention to safety.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div>Medical Software Development<\/h2><\/div>Medical Device software follows a specific scheme of planning, drafting, verification and documentation, adjusted for the level of risk in case of error, according to EN 62304 (Medical Software Lifecycle).<\/p>\n
We can structure mission-critical software for each of the three classes defined by the standard (A, B, C). Through meticulous planning, we can develop software involved in high-risk processes for Patients and Operators. <\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div>Human-Machine Interfaces<\/h2><\/div>We develop interaction systems of varying complexity and Human-Machine Interfaces via touchscreen displays by leveraging our expertise in the embedded domain.<\/p>\n
We realize simple operator interfaces controlled directly by microcontrollers and complex projects by leveraging frameworks including JavaFX and QT\u00ae in the Linux\u00ae environment.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div>Compliance Assistance<\/h2><\/div>The marketing of most of the Medical Devices we develop requires the involvement of a Notified Body for verification of type conformity (the product conforms to design specifications) and of the quality of production.<\/p>\n
We produce all or part of the technical dossiers, complete with Essential Requirements, Risk Analysis, Clinical Analysis, Usability Analysis, Software documentation, Validation, test reports from Accredited Laboratories, Follow-up procedures.<\/p>\n
We support our clients by interacting with the Notified Bodies that perform the analysis<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div>Electromedical production<\/h2><\/div>Our Quality Management System is ISO 13485 certified for the production of Electromedical Devices. We strictly follow internal procedures and production documentation to ensure compliance with the approved type. <\/p>\n
We fully manage the traceability of critical components at the time of purchase and at all stages of processing.<\/p>\n
We carry out testing, safety testing and end-of-line testing on each product.<\/p>\n
We follow production through to labeling and packaging.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
The creation of an Electromedical Device is a multifaceted process that combines the needs of medical practice with safeguarding the health and safety of Patients and Operators.<\/p>\n
For this reason, the lifecycle of Medical Devices is strictly regulated and must be competently followed as early as the planning stage.<\/p>\n
Technological advances must be supported by precise scientific evidence and systematic risk-benefit analysis, which go far beyond simple product engineering.<\/p>\n
We support our clients from the early planning stages, collaborating with medical personnel, consultants in specialized fields and Notified Bodies.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Electromedical Design<\/h2><\/div>We design the components of each electromedical system by collaborating with customers and medical personnel in defining the requirements.<\/p>\n
Whether it is the structural or design elements, the automation and electronic parts, or the software functionality, we carefully develop each element with expertise and attention to safety.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div>Medical Software Development<\/h2><\/div>Medical Device software follows a specific scheme of planning, drafting, verification and documentation, adjusted for the level of risk in case of error, according to EN 62304 (Medical Software Lifecycle).<\/p>\n
We can structure mission-critical software for each of the three classes defined by the standard (A, B, C). Through meticulous planning, we can develop software involved in high-risk processes for Patients and Operators. <\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div>Human-Machine Interfaces<\/h2><\/div>We develop interaction systems of varying complexity and Human-Machine Interfaces via touchscreen displays by leveraging our expertise in the embedded domain.<\/p>\n
We realize simple operator interfaces controlled directly by microcontrollers and complex projects by leveraging frameworks including JavaFX and QT\u00ae in the Linux\u00ae environment.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div>Compliance Assistance<\/h2><\/div>The marketing of most of the Medical Devices we develop requires the involvement of a Notified Body for verification of type conformity (the product conforms to design specifications) and of the quality of production.<\/p>\n
We produce all or part of the technical dossiers, complete with Essential Requirements, Risk Analysis, Clinical Analysis, Usability Analysis, Software documentation, Validation, test reports from Accredited Laboratories, Follow-up procedures.<\/p>\n
We support our clients by interacting with the Notified Bodies that perform the analysis<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div>Electromedical production<\/h2><\/div>Our Quality Management System is ISO 13485 certified for the production of Electromedical Devices. We strictly follow internal procedures and production documentation to ensure compliance with the approved type. <\/p>\n
We fully manage the traceability of critical components at the time of purchase and at all stages of processing.<\/p>\n
We carry out testing, safety testing and end-of-line testing on each product.<\/p>\n
We follow production through to labeling and packaging.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
We design the components of each electromedical system by collaborating with customers and medical personnel in defining the requirements.<\/p>\n
Whether it is the structural or design elements, the automation and electronic parts, or the software functionality, we carefully develop each element with expertise and attention to safety.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Medical Software Development<\/h2><\/div>Medical Device software follows a specific scheme of planning, drafting, verification and documentation, adjusted for the level of risk in case of error, according to EN 62304 (Medical Software Lifecycle).<\/p>\n
We can structure mission-critical software for each of the three classes defined by the standard (A, B, C). Through meticulous planning, we can develop software involved in high-risk processes for Patients and Operators. <\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div>Human-Machine Interfaces<\/h2><\/div>We develop interaction systems of varying complexity and Human-Machine Interfaces via touchscreen displays by leveraging our expertise in the embedded domain.<\/p>\n
We realize simple operator interfaces controlled directly by microcontrollers and complex projects by leveraging frameworks including JavaFX and QT\u00ae in the Linux\u00ae environment.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div>Compliance Assistance<\/h2><\/div>The marketing of most of the Medical Devices we develop requires the involvement of a Notified Body for verification of type conformity (the product conforms to design specifications) and of the quality of production.<\/p>\n
We produce all or part of the technical dossiers, complete with Essential Requirements, Risk Analysis, Clinical Analysis, Usability Analysis, Software documentation, Validation, test reports from Accredited Laboratories, Follow-up procedures.<\/p>\n
We support our clients by interacting with the Notified Bodies that perform the analysis<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div>Electromedical production<\/h2><\/div>Our Quality Management System is ISO 13485 certified for the production of Electromedical Devices. We strictly follow internal procedures and production documentation to ensure compliance with the approved type. <\/p>\n
We fully manage the traceability of critical components at the time of purchase and at all stages of processing.<\/p>\n
We carry out testing, safety testing and end-of-line testing on each product.<\/p>\n
We follow production through to labeling and packaging.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Medical Device software follows a specific scheme of planning, drafting, verification and documentation, adjusted for the level of risk in case of error, according to EN 62304 (Medical Software Lifecycle).<\/p>\n
We can structure mission-critical software for each of the three classes defined by the standard (A, B, C). Through meticulous planning, we can develop software involved in high-risk processes for Patients and Operators. <\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Human-Machine Interfaces<\/h2><\/div>We develop interaction systems of varying complexity and Human-Machine Interfaces via touchscreen displays by leveraging our expertise in the embedded domain.<\/p>\n
We realize simple operator interfaces controlled directly by microcontrollers and complex projects by leveraging frameworks including JavaFX and QT\u00ae in the Linux\u00ae environment.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div>Compliance Assistance<\/h2><\/div>The marketing of most of the Medical Devices we develop requires the involvement of a Notified Body for verification of type conformity (the product conforms to design specifications) and of the quality of production.<\/p>\n
We produce all or part of the technical dossiers, complete with Essential Requirements, Risk Analysis, Clinical Analysis, Usability Analysis, Software documentation, Validation, test reports from Accredited Laboratories, Follow-up procedures.<\/p>\n
We support our clients by interacting with the Notified Bodies that perform the analysis<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div>Electromedical production<\/h2><\/div>Our Quality Management System is ISO 13485 certified for the production of Electromedical Devices. We strictly follow internal procedures and production documentation to ensure compliance with the approved type. <\/p>\n
We fully manage the traceability of critical components at the time of purchase and at all stages of processing.<\/p>\n
We carry out testing, safety testing and end-of-line testing on each product.<\/p>\n
We follow production through to labeling and packaging.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
We develop interaction systems of varying complexity and Human-Machine Interfaces via touchscreen displays by leveraging our expertise in the embedded domain.<\/p>\n
We realize simple operator interfaces controlled directly by microcontrollers and complex projects by leveraging frameworks including JavaFX and QT\u00ae in the Linux\u00ae environment.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Compliance Assistance<\/h2><\/div>The marketing of most of the Medical Devices we develop requires the involvement of a Notified Body for verification of type conformity (the product conforms to design specifications) and of the quality of production.<\/p>\n
We produce all or part of the technical dossiers, complete with Essential Requirements, Risk Analysis, Clinical Analysis, Usability Analysis, Software documentation, Validation, test reports from Accredited Laboratories, Follow-up procedures.<\/p>\n
We support our clients by interacting with the Notified Bodies that perform the analysis<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div>Electromedical production<\/h2><\/div>Our Quality Management System is ISO 13485 certified for the production of Electromedical Devices. We strictly follow internal procedures and production documentation to ensure compliance with the approved type. <\/p>\n
We fully manage the traceability of critical components at the time of purchase and at all stages of processing.<\/p>\n
We carry out testing, safety testing and end-of-line testing on each product.<\/p>\n
We follow production through to labeling and packaging.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
The marketing of most of the Medical Devices we develop requires the involvement of a Notified Body for verification of type conformity (the product conforms to design specifications) and of the quality of production.<\/p>\n
We produce all or part of the technical dossiers, complete with Essential Requirements, Risk Analysis, Clinical Analysis, Usability Analysis, Software documentation, Validation, test reports from Accredited Laboratories, Follow-up procedures.<\/p>\n
We support our clients by interacting with the Notified Bodies that perform the analysis<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Electromedical production<\/h2><\/div>Our Quality Management System is ISO 13485 certified for the production of Electromedical Devices. We strictly follow internal procedures and production documentation to ensure compliance with the approved type. <\/p>\n
We fully manage the traceability of critical components at the time of purchase and at all stages of processing.<\/p>\n
We carry out testing, safety testing and end-of-line testing on each product.<\/p>\n
We follow production through to labeling and packaging.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Our Quality Management System is ISO 13485 certified for the production of Electromedical Devices. We strictly follow internal procedures and production documentation to ensure compliance with the approved type. <\/p>\n
We fully manage the traceability of critical components at the time of purchase and at all stages of processing.<\/p>\n
We carry out testing, safety testing and end-of-line testing on each product.<\/p>\n
We follow production through to labeling and packaging.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>