Medical devices, robotic assistance systems, digital health or diagnostics solutions – as an ISO 13485-certified engineering partner, our interdisciplinary team develops holistic healthcare solutions that bring everyone on board. Let us join forces to shape the things to come in healthcare technology.
We provide local Japanese language sales, project management and engineering. For medical projects under ISO 13485:2016 we rely on our R&D headquarter in Germany which is certificated foreign medical device manufacturer pursuant to Article 23-2-4 of the Act on Pharmaceuticals and Medical Devices.
Our services
Standards-compliant system and software development
As an ISO 13485-certified software and system development partner of long standing, we support you by pursuing a standards-compliant approach to throughout the development cycle, from the feasibility study to the finished product. This is how we clear every obstacle on your path to certification (MDR/IVDR, FDA). Once your product is certified, we can stay on board to provide maintenance and support to help keep it on the cutting edge.
What we do at a glance:
Requirements Engineering
Software
Usability
Hardware
Mechanics
Verification
Maintenance
Digital health solutions
Your ideas for innovative medical products are helping to move healthcare towards a bright digital future. From developing embedded software and desktop and mobile applications to wearables – we support you at every step of your way. Our top priority: your medical product’s approvability and usability.
What we do at a glance:
Standards-compliant development and documentation
Front-ends/ back-ends/ apps
Embedded and real-time systems
Verification
Prototyping
Connectivity and cyber security
We connect your medical devices to ensure information is accessible at every need-to-know point. Drawing on our device connectivity skills and functional and cyber security expertise, we also make sure your medical product is protected against cyber attacks. Our specialists team up with yours to develop a holistic, security-by-design concept to guard your systems against threats.
What we do at a glance:
Connecting devices
Interfaces to HIS/PACS/LIMS/EMR systems
Security risk assessment
Basic security concept
Consideration of cyber security, information security and data protection
Quality assurance
Medical devices are subject to strict regulations. We understand the importance of quality and have a great deal of experience complying with standards and regulations. As your go-to development partner, we are with you for the long haul, providing advice and operational support throughout the product lifecycle. Call on us to help you achieve your quality goals and to jointly develop your medical products to the latest standards.
Scope of engineering and consulting support:
EN ISO 13485:2016 QM system
PMDA accreditation as foreign medical device manufacturer
IEC 62366-1:2020 usability engineering
ISO 14971:2019 risk management
IEC 62304:2015 software lifecycle
MDR, IVDR, FDA regulatory affairs
DIN EN 60601-1:2020 medical electrical equipment device
IEC 80001:2021 security
IEC 61508:2010 safety
Expertise
Unlock the power of advanced robotics
Our roots in robotics run deep with nearly 30 years to our credit. Time in which we wrote millions of lines of code for robotic assistance systems. Whether surgical robots, mobile platforms, or robotic support in nursing and rehabilitation – our robotics team inspires with its firm grasp of methods and technology know-how for individual system solutions that master every move.
State-of-the-art operating rooms exhibit a high degree of connectivity both between individual medical devices and within the hospital’s IT systems. OR integration solutions offer significant benefits in terms of improving operating room efficiency, cutting costs, and reducing administrative overhead.
Partners on the path to your approvable medical device
Your ideas for innovative medical products are helping to move healthcare towards a bright digital future. Our Digital Health Microservices Platform speeds up your time to market and puts you on a safe path to turning your idea into an approvable medical product.
Medical robotics: The journey from inceptive idea to finished product
The use of robotic systems in healthcare will continue to expand in the years ahead, paving the way for groundbreaking new opportunities in medical technology that will benefit both medical practitioners and patients. This whitepaper provides an overview of the key requirements and development steps from the evaluation of the product idea to the CE mark.
As your German engineering partner for tailor-made system development, we can help you turn your idea into an approvable product and provide continued support beyond its release. We value openness. We cultivate close relationships. And we are in this with you for the long term. Joining forces with you, we want to develop safe, connected healthcare solutions that benefit people and society as a whole.
