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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 software for OCT scanners

Touch user interfaces for various medical devices

Web-based medical applications

USB-Stack

RFID

Various on-board and cable-transmitted communication interfaces

Real-time software and planning software for motion control of complex optomechatronic systems

Battery monitoring and management solutions

Safety applications for medical devices

- Cryptography
- RFID Applications
- secure remote updates


Technologies

The following technologies are mainly used:

Hardware and Plattforms

Hardware and Plattforms

- Linux / Windows
- Keil RTX 5
- Secure Remote-Updates
- STM32 & TI uC
- LiPo Battery Management Controllers
Software

Software

- C, C++, C# for all levels of concern / risk classes
- Matlab / Mathematica
- various performance analysis tools
- GUI (QML, WPF)
- Cryptography
Web-based Software

Web-based Software

- Java EE
- PHP
- Symfony 3 & 4
- MySQL / Maria DB
- PostgreSQL


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 (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

Software Development for MedTech according to ISO 13485, ISO 62304 and FDA

Software development in medical technology requires, among other things, a software life cycle. ISS AG offers software development under an IEC 62304 certified process. Our many years of experience will get your project to its destination on time and within budget. We stand for high quality products that fully meet the requirements of patient safety.

Outsourcing of Development according to IEC 62304/IEC 82304

If the development and maintenance of software for medical devices is not part of your company's core competence, outsourcing these activities allows you to keep your focus.

Because we have implemented the necessary processes, our customers can outsource not only the development but the entire software lifecycle management including technical documentation, problem tracking, maintenance processes and software release as needed.

ISS Bootloader

Firmware updates in-field are a challenge for many active medical devices. Based on several implementations for demanding medical device applications, a generic bootloader core was developed that can be flexibly embedded into medical device firmware and allows for a secure distribution and installation of such firmware updates.

By using the ISS bootloader, a lot of development time can be saved and added value can be generated in the area of secure remote updates.

RFID

Disposables / consumables are becoming an increasingly important part of the business model. ISS AG has developed an RFID-supported concept that offers the highest possible copy protection and additional security features, while at the same time being extremely user-friendly. Marketing and sales thus open up new ways for innovative business models, with great customer proximity, added value and customer loyalty.

Embedded Linux

Medical devices are often based on embedded Linux, with specific requirements for the toolchain and the base system. ISS AG configured and developed system images and toolchains based on Yocto Linux and Ubuntu to provide a reliable platform for the application software with a controllable update process.

Embedded Windows

Complex medical devices are often controlled by application software that depends on Microsoft Windows. Both consumer and enterprise Windows systems are unsuitable for medical devices due to the complexity of their maintenance. Windows IoT is the platform for industrial systems and is successfully used by ISS AG in several customer projects for medical devices.

Ready-To-Market Medical Device Software

Thanks to our many years of experience in the areas of software development for medical devices, regulatory affairs and product maintenance, we are the ideal partner to help you achieve and maintain market readiness and CE certification for medical device software.


Contact

Andreas Mueller Website

Andreas Müller

Tel. +41 32 513 67 83 | This email address is being protected from spambots. You need JavaScript enabled to view it.

Head of Software Development