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.

For this reason, the lifecycle of Medical Devices is strictly regulated and must be competently followed as early as the planning stage.

Technological advances must be supported by precise scientific evidence and systematic risk-benefit analysis, which go far beyond simple product engineering.

We support our clients from the early planning stages, collaborating with medical personnel, consultants in specialized fields and Notified Bodies.

We design the components of each electromedical system by collaborating with customers and medical personnel in defining the requirements.

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.

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).

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.

We develop interaction systems of varying complexity and Human-Machine Interfaces via touchscreen displays by leveraging our expertise in the embedded domain.

We realize simple operator interfaces controlled directly by microcontrollers and complex projects by leveraging frameworks including JavaFX and QT® in the Linux® environment.

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.

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.

We support our clients by interacting with the Notified Bodies that perform the analysis

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.

We fully manage the traceability of critical components at the time of purchase and at all stages of processing.

We carry out testing, safety testing and end-of-line testing on each product.

We follow production through to labeling and packaging.