DEVELOP­MENT PARTNER FOR YOUR MEDICAL PRODUCTS

Since 2009, we have been supporting our customers in the development of innovative HMI solutions in medical technology. We are also happy to support your software project from the very beginning with the new or further development of desktop, embedded or mobile applications.

In our long-standing projects, we work on equal terms as an extended workbench, process and technology consultant and sparring partner.

NORMS & STANDARDS

To ensure the smooth placing on the market of your medical device, we take into account the following norms and standards.

DIN EN ISO 13485:2016

Quality Management

A comprehensive quality management system is required for the design and manufacture of medical devices. The focus is on product safety and effectiveness.

IEC 62304:2016

Software Life Cycle

Minimum requirements for key software lifecycle processes (development, maintenance, risk management, software configuration management, and software problem resolution).

DIN EN ISO 14971:2018

Risk Management

In order to identify the hazards associated with medical devices, the risks must be assessed, evaluated and regularly controlled.

DIN EN ISO 82304-1:2017

Product Safety

For so-called 'stand-alone' software, a procedure is suggested here that identifies and manages risks that could arise when using the software.

IEC 62366:2017

Usability

Medical software is highly complex. But the user interface should not be. Users depend on intuitive operation in their routine situations.

DIN EN ISO 9241-110 2008-09 und -210:2011

Human-Machine-Interface

Human-Machine-Interface (HMI) ergonomics guidelines and dialog design principles are important components in user interface design (UI/UX). 

AGILE SOFTWARE DEVELOP­­MENT FOR MEDICAL DEVICES

When implementing your medical products, we largely dispense with requirement and functional specifications. Instead, we focus on an agile approach so that we can bring your product to market quickly and with high quality. In order to meet the documentation requirements of medical software according to MDR, ISO 13485 and IEC 62304, we use Application Lifecycle Management (ALM) systems and/or ticket systems according to defined quality management processes.

Agile Scrum method in line with software development process according to IEC 62304 (Medical device software)

REFERENCES

EIZO OR Monitor

Development of a software for touchless switching of a monitor-layout in operating rooms using hand gestures and voice commands.

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