We keep an eye on your software

The complete solution for all social institutions

Due to the large number of software products and vendors, it is difficult to keep track. We provide you with our expert knowledge and a comprehensive package of measures and help you to ensure that your medical devices operate in compliance with the law and are compatible.

 

This is what you should be aware of:

  • Which software is approved as a medical device in your institution?
  • Do your own developments count as medical devices?
  • Is compatible operation according to the manufacturer's specifications guaranteed?
  • Is the used software listed in an inventory?
  • Do you subject your software to a recurring technical safety test?
  • Do you make adjustments to your software as a medical device or do you develop extensions based on your medical device software yourself?

 

With the end of the transition period to the new European Medical Device Regulation (MDR), higher requirements apply to medical devices. Especially for software as a medical device, stricter rules and more obligations for operators arise.

 

Our services in detail:

Medical Software Compliance Check

Ensuring compatibility

With the Medical Software Compliance Check, x-tention offers a quick and easy way to identify and analyse software medical devices. With a comprehensive action tool, we ensure absolute transparency for compliance with all legal requirements.

  1. Analysis of in-house software
  2. Classification of software as a medical device according to manufacturer specifications
  3. Testing of compatibility according to manufacturer specifications and legal requirements
  4. Compliance certificate for current compatibility of software as a medical device

 

Recurring technical safety inspection

Ensuring functionality and patient safety

Since 2019 we have been in cooperation with TÜV Austria. This gives you the opportunity to have your software as a medical device subjected to a recurring safety test at an accredited test partner (short: wSTP or STK). Just as with physical medical devices, regular testing of software as a medical device is required by law. Take the first step towards recurring safety testing of software as a medical device!

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Consulting for your own development

What's in the field? What is a medical device? What is to be done according to MDR?

  1. Analysis regarding existing software enhancements
  2. Classification of extensions as potential medical or non-medical devices
  3. Support for the differentiation between medical and non-medical device
  4. Information regarding required documentation and processes according to MDR as well as support in establishing an ISO13485 quality management system 
  5. Process development for a compatible operation and implementation of the Medical Software Compliance Check

 

Consulting on ISO13485

We support you in establishing a quality management system for medical devices according to ISO13485. Benefit from our many years of experience in the healthcare sector and save valuable time with our practical template packages.

Your advantages

  • We are experts and know the industry and daily challenges in healthcare and social services
  • Compact and transparent overview through inclusion of software as a medical device into the inventory and recurring safety checks
  • Simple implementation of measures and support up to MDR conformity
  • Full control with little effort
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Broschürenbild Software als Medizinprodukt
Broschüre Software als Medizinprodukt
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