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?
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. This makes it essential to choose your software development partner carefully.
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.
EU Medical Device Regulation (EU MDR) – CE marking
US FDA Medical Device Regulation
ISO 13485 – Quality Management (QMS)
IEC 62304 – Sofware 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.
Amongst other projects, we have created an enterprise resource planning system for a positron emission tomography (PET) center, dental X-ray imaging software, and software for a wide range of medical devices. Our clients include PulseOn, Revenio, Novasano, Nexstim, and Palodex Group.
In addition to software development, we offer services such as consulting and user experience planning.
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.
Learn more about usability requirements for medical devices – download our white paper!
Medical software testing according to ISO 13485 – what to consider?
From the point of view of patient safety it is crucial that medical devices work correctly – the worst possible consequence of an error could be lost human life. Testing plays an important role in ensuring the quality of the medical device. What are the most important things to consider in planning and implementing effective and standard-compliant testing of medical software?
Download our white paper and learn more about medical software testing!
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.
The development of software for medical devices differs in many respects from other software development. Read more about the topic: Medical software development – how does it differ from other software development?
Need help and expertise in developing a medical device or software? Book a meeting with us!
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