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.
Cloud Solution for Compliant Medical Device Software (MDSW)
Medical applications, even seemingly simple ones like medical calculators, are considered medical devices. Therefore, they must meet stringent regulatory requirements, leading to complex and costly development and operations.
We offer an innovative solution to address these challenges – our digital platform. The key principle of our platform is the segregation of non-medical devices and medical devices. This means that a digital application, such as a medical calculator, can be developed, in compliance with the regulations, on the ISS Digital Platform. As a user, you have the option to use these medical calculators independently or integrate them into your existing information system. The digital module will remain a medical device, thanks to our compliant development and operations on our platform.
The ISS Digital Platform provides the answer to the complex requirements of digital medical device development and integration. Learn more in our flyer or contact us directly for more information.
Your advantages at a glance:
Cost Control
thanks to the innovative cloud concept that ensures the segregation of medical device modules from non medical device modules.
Regulatory Assurance
with our regulatory affairs experts who ensure compliance with all requirements.
Seamless Integration
into existing systems (e.g. HIS) with standardized REST-APIs.
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
Technologies
The following technologies are mainly used:
Hardware and Plattforms
Software
Web-based Software
Project Examples
- 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
- 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
RFID
Embedded Linux
Embedded Windows
Ready-To-Market Medical Device Software
Contact
