Software as a Medical Device

As a medical software development partner, we have had a quality management system (QMS) in accordance with ISO 13485 and proven experience in creating applications that comply with CE and FDA.

Create your dedicated solution with our specialists by both legal and medical requirements.

Software as a Medical Device

As a medical software development partner, we have had a quality management system (QMS) in accordance with ISO 13485 and proven experience in creating applications that comply with CE and FDA.

Create your dedicated solution with our specialists by both legal and medical requirements.

 Software as a Medical Device services we provide

Certified medical software development

We’ll provide you with full-cycle medical application development support, followed by regulatory-compliant technical documentation and risk assessment. We will guide you through the precise definition of objectives and responsibilities, qualification of the medical device class and delivery of MDR and FDA compliant documentation.

ISO 13485, CE, FDA competence

We have competences and experience to develop software meets ISO 13485 standard and complies with CE and FDA.

ISO 14971 and IEC 62304 standard competence

We have competences and experience to develop software meets ISO 13485 standard and complies with CE and FDA.

Software as a Medical Device (SaMD)

We will realize your idea and provide you Software as a Medical Device tailored to your expectations – faster. We work according to a ready and developed workflows compliant with the technological and regulatory requirements for medical device solutions – from PoC, through the development phase, to delivering a final solution. We will provide all technical documentation needed for the CE/FDA certification as well as risk analysis.

Quality Management System

We base our work on internal Quality Management System.

Documentation for certification

During the project we create documentation in accordance with medical standards wich will support and accelerate the certification process of your solution in the future.

Contact out team

Let’s talk about the details of your Sofware as a Medical Device project.

We can create and develop it together.

Software as a Medical Device solutions

There’s a lot we can help you with.

Custom medical device software development

We have a solid understanding of what software as a medical device manufacturing is all about. Thanks to our experience, we are able to assist you at every stage of the project and will provide you with all the technical documentation that is required during certification.

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Initial meeting and (followed by) gathering requirements
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Technical and medical assessment of the project
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Definition of objectives and responsibilities in the project
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Preparing ballpark estimation and technical risk analysis
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Start of the project on the basis of predetermined arrangements
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Project development supplemented by governance meetings
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Product release with MDR / FDA compliant documentation

WE’VE GOT YOU COVERED 

Regulatory for medical device software 

Understanding the medical software legal requirements can be complex to navigate. It doesn’t matter if the path you take is to meet the requirements of the MDR, IVDR, FDA or DiGA standard – we will traverse it with you from code to documentation.

Check our competences in Medical Device Regulation (MDR), ISO 13485 and more

We have prepared a document template for you.

Find out what kind of certification documents we can create for you during medical device software development project (click here) or leave us your contact information and you will be able to download the template document we have prepared.

Let’s work on your challenges together!

Contact us:

Let’s work on your challenges together!

Contact us: