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Software for medical devices

Development and certification of software for medical devices in accordance with IEC 62304 - from embedded firmware to the cloud. Our many years of experience and ISO 13485 certification guarantee high quality, pre-certified software and regulatory compliance. This enables our customers to focus on their core competencies and reach their goals faster.

Special know-how

ISO 13485 - Quality management system

We are certified and work according to ISO 13485 to ensure that our medical devices meet the highest quality and safety requirements. Our quality management system is designed to ensure continuous improvement and regulatory compliance.

Software development according to IEC 62304

We develop our software in accordance with the IEC 62304 standard, which regulates the software lifecycle in medical technology. Our processes ensure compliance with safety and performance requirements throughout the entire development cycle.

Requirements Engineering

Our expertise in requirements engineering enables us to precisely capture complex requirements and translate them into efficient and reliable software solutions. By working closely with our customers, we ensure that every solution is tailor-made and future-proof.

Documentation

We attach great importance to detailed and comprehensive documentation that covers all aspects of the development process. Our documentation meets the highest quality standards and is essential for regulatory approval and proof of product conformity.

Risk management

We support our customers with risk management. Risks are identified and monitored throughout the entire development process. Through preventive measures and continuous monitoring, we ensure that potential risks are minimized.

Security, data protection

We integrate advanced security and data protection mechanisms to ensure the integrity and confidentiality of critical data. Our solutions protect sensitive information from unauthorized access.

Device update capability

Our solutions include advanced update mechanisms that enable devices to be updated securely and efficiently. This ensures that systems are always up to date and protected against security threats.

Automated processes CI/ CD

We implement automated CI/CD processes that optimize the software lifecycle of medical devices. Our solutions ensure that updates and new features are provided quickly and reliably, keeping systems up-to-date and efficient at all times.

Device update capability

Our solutions include advanced update mechanisms that make it possible to update devices securely and efficiently. This ensures that your systems are always up to date and protected against security threats.

Medical device development since 2005

We are certified to ISO 13485 and develop software for medical devices in accordance with international standards such as the IEC 62304 software lifecycle process and the IEC 14971 risk management standard. We support you with risk management, documentation and software development and ensure traceability throughout the entire software lifecycle - a prerequisite for the approval of your product.

Thanks to our many years of experience in working with market leaders in the field of medical technology, we are very familiar with these requirements and deliver the appropriate solutions. For you, this means that we can seamlessly integrate our software into your processes as the manufacturer and "marketer" of the medical technology product.

Medical devices and their development phases are often highly complex. Most developments involve special know-how and high investments. We actively contribute to simplifying the complexities in the conception and implementation phase. Be it through the use of proven and sensible technologies to make the product robust in daily use or through optimized processes for correct documentation under medical law (e.g. according to software life cycle IEC 62304).

Read all the details about our specialist know-how below.

Selected customer projects

media alt text Sensor for ultrasonic probes Ultrasonic probes with highly sensitive sensors help to detect movements and events. media alt text Smart prosthesis control Intelligent prosthesis control with electrode pattern recognition for individual adaptation to the patient. media alt text Gait analysis software Precise analysis of the gait pattern using PC evaluation of movement and pressure data from sensor soles. media alt text HIL system for medical device Hardware-in-the-loop test system for the automatic system test of a pulsed cardiac catheter system. media alt text Smartphone app for prostheses Configuration and training app for customizing the ottobock Myo Plus prosthesis control. media alt text Digital therapy pen ErgoPen from STABILO uses sensor evaluation to detect abnormalities when writing and provides recommendations. media alt text Health check platform Health check by analyzing vital parameters such as height and weight, blood pressure, resting heart rate.
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Our use cases

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Your contact person

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Andreas Lehner, MSc

Head of Innovation, Sales

blue-zone GmbH

T +43 7236 78500-25

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