Medical Software Development according to ISO 13485/IEC 62304
Due to our experience in software development, we are able to develop, verify, validate and maintain entire software products and also sub-projects both efficiently and compliantly. Development processes help us to fulfil the applicable requirements, such as IEC 62304, CE and FDA. The ISO 13485 certification gives us the authorization for "Development and development services for hardware and embedded software for medical products as well as stand-alone software as medical products.".
Our team develops exclusively for customers from the medical technology sector. All necessary processes are implemented, the tools used are validated and the corresponding procedures and documentation structures are lean and well established. The broad positioning of ISS AG (Regulatory Affairs, Quality Management, SW-Development, Clinicals) also benefits your software projects and favours an efficient product approval and thus a fast market access. If you see bottlenecks in your resources, we support you in completing your product on time.
Our Skills and Expertise
We have a team of software engineers with strong hardware and electronics backgrounds. This enables us to support customers beyond software development also on hardware level. Since SW and HW interact strongly with each other, our SW engineers are also available to advise on HW development.
For many years we have been developing software and firmware for medical devices with our own IEC 62304 compliant processes and tools in our QMS or under the QMS of our customers. Many of these software products are now part of approved medical devices and have been used in millions of patients.
Our skills and expertise include among others:
Medical image and signal processing
Development and maintenance of embedded software, standalone software and webapplications
Touchscreen user interfaces for various medical devices
Database design and implementation for webapplications and standalone software
USB-Stack for most used interfaces
Wireless communication via RFID, Bluetooth, ANT, Wifi
Robust handling of various on-board and wired communication interfaces
Real-time software and efficient multithreading
Battery monitoring and management solutions
Security development lifecycle
Development of prototypes and small series for clinical studies
Integration of risk management according to ISO 14971
The following technologies are mainly used:
Hardware and Plattforms
- System design for a completely new diagnostic measurement technique
- User interface for controlling a new EAN Powertool console for multiple engines
- Firmware development for a medical, battery operated handheld device
- Patient-specific prediction and surgery planning in refractive surgery (Optimeyes)
- Software and firmware for a diagnostic device for urology and gynecology
- Software and firmware for hardware control, data acquisition and data preparation of a diagnostic device for ophthalmology with three different measuring methods.
Solutions and Factsheets
Medtech Software Engineering
Ready-To-Market Medical Device Software
Division Leader Digital MedTech