Tailor-made systems for medical devices

A systematic approach to requirements engineering at the beginning of a project is the first stepping stone towards progress and the final gateway to success. With a firm grasp of methods and medical engineering skills honed over many years, we help determine, document, and verify the requirements for your system to spare you costly changes in later phases of the project. Call on us to

• Determine stakeholder requirements
• Develop manageable user stories
• Draw up proof of concepts

With emerging new opportunities comes greater complexity. As your ISO 13485-certified partner for standards-compliant software and systems development, we lighten your workload by delivering innovation, architecture and security concepts, as well as standards-compliant solutions that are traceable all the way to the finished OEM product.

Software

• Software architecture
• Software design
• Implementation
• Verification and integration
• Tool and/ or SOUP validation
• Algorithms, AI, image processing
• User interface design/ user experience

Hardware

• Hardware design: Circuit design, layout (multilayer PCBs), circuit simulation
• Verified building blocks
• Medically safe industrial interfaces
• Embedded controllers and Linux modules
• Connectivity and remote control

Mechanics

• Design and dimensioning of mechanical precision parts
• Housing, supporting structure, cooling, display integration
• Prototyping
• Production-ready design
• Robotics and assistance systems

Certification marks the beginning of a new phase in a product’s lifecycle. Regular maintenance and updates are very much part of that lifecycle and have to be factored into the equation. Digital tools for application lifecycle management are required for the efficient application of processes throughout the entire product lifecycle. We will be happy to help you choose and use our advanced Polarion ALM modules.

• Lifecycle management
• Product updates
• Maintenance & support

Medical devices are subject to strict regulations. The new MDR sets out even more stringent rules in the interest of the highest priority, patient safety. 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 despite deadline pressure. Count on us to jointly develop your medical products to the latest standards. Let us clear every obstacle from your path to certification.

• EN ISO 13485:2016 QM system
• IEC 62366-1:2015+COR1:2015+A1:2020 usability engineering
• ISO 14971:2019 risk management
• IEC 62304:2006+A1:2015 software lifecycle
• MDR:2017 regulatory affairs, FDA, IVDR
• DIN EN 60601- 1:2013 medical electrical equipment safety
• IEC 80001 security
• IEC 61508 safety