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MEDICAL DEVICES

Faster time to market for your medical device or application

Are you developing a medical device or software that you want to market effectively without compromising on quality? Atostek is your ISO 13485 certified partner for the development of safe and reliable medical software.

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Software Development and Solutions for Medical Devices

The software development of a medical device is carefully regulated, from the design stage all the way until the software has been approved. Knowledge of the industry’s quality requirements and carefully planned and executed actions play an important role throughout the process of ensuring human health and safety.

We specialise in cutting-edge software services and solutions that meet the stringent requirements of medical devices.

Our Solutions

Flexbot

Our specification-driven framework empowers you to develop robust software for medical robotics, driving the future of automated healthcare. With Flexbot, you can accelerate product development and save on costs while considering the strict safety requirements of medical devices and software.

Clinibus

Clinibus is a customizable platform solution for social and health care as well as health technology needs. With this solution, you can collect, process, and display data from your medical device. Clinibus is based on Atostek ERA.

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FHIRWORX

Looking to enhance the operations of your healthcare organization? Do the integrations of information systems seem too complicated? Our FHIRWORX service helps you integrate with patient information systems, implement artificial intelligence and analytics, and gather all the essential data you need in one place.

Software Engineering

Are you looking for an ISO 13485 certified partner for software development of medical devices? We create software that meets the strict requirements of medical devices and takes your business to the next level.

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Our Guarantee

Atostek offers services for the software development of medical devices. We have been awarded the ISO 13485 certificate for medical devices and software, which applies to development of medical software for clients. We also guarantee that we operate in accordance with the applicable regulatory requirements.

Regulations

  • EU Medical Device Regulation (EU MDR) – CE marking
  • US FDA Medical Device Regulation

Standards

  • ISO 13485 – Quality Management
  • IEC 62304 – Software Lifecycle
  • ISO 14971 – Risk Management
  • IEC 62366 – Usability

Atostek Compliance Framework

The Atostek Compliance Framework (ACF) ensures that our processes and ways of working comply with the European Union (MDR) and the FDA’s regulations regarding medical devices. This ensures that your software will pass the strict requirements applied for medical devices.

By choosing Atostek as your partner, you can rest assured that your software is developed in accordance with the ISO 13485 and ISO 9001 standards and that it will be eligible for the CE marking. We will also provide you with a scalable operating environment or take care of operations during production, if necessary.

Selected References

Technology: integrations and platform solutions

A seamless flow of information is vital in the medical field. We make sure that the systems used are mutually compatible, and we create the necessary solutions. We have expertise in communication standards and technologies such as HL7 CDA R2, FHIR, DICOM, and XDS.

We create scalable production environments using various means, such as public cloud platforms. We have implemented applications and solutions based on public cloud platforms for many of our clients. The platforms we use the most are Microsoft Azure and Amazon AWS.

Implementing the FHIR standard in healthcare: why is gradual implementation the key to success?

Implementing the FHIR standard in healthcare: why is gradual implementation the key to success?

The FHIR standard for healthcare interoperability is gaining popularity due to its numerous benefits. With the aid of the FHIR standard, social and healthcare information systems can be implemented gradually.

The new old world of imaging

The new old world of imaging

However, the journey from the machine to the computer screen for the doctor to view the X-ray is not a straightforward one. In the 1990s, the DICOM standard for digital imaging was developed, and is still the de facto standard from large hospitals to small clinics. DICOM is nothing new, but now it is back on the agenda.

Medical software development – how does it differ from other software development?

Medical software development – how does it differ from other software development?

By medical device we mean, for example, a device, software or instrument that is used to diagnose or treat patients. The software itself may be a medical device, or software can be used to control the operation of a medical device.

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Medical Software Testing According to ISO 13485 – 5 Things to Consider

What are the most important things to consider in planning and implementing effective and standard-compliant testing of medical software?

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How to Design Medical Device Usability

Are you planning to design and market a medical device, either a physical one or a SaMD (Software as a Medical Device)? According to regulatory requirements, considering usability is mandatory. You have to apply the IEC 62366-1 standard in the design and evaluation process – the primary purpose of usability is to consider patient safety.

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Juho Leppämäki

Sales, Medical Devices
Quality Manager
juho.leppamaki@atostek.com
+358 45 113 8883

Juhani Perhonen

Chief Business Developer
juhani.perhonen@atostek.com
+1 914 530 4069 (USA)
+358 45 7834 5589

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