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Consultation for medical software

Our Experience for your Safety

Software development according to EN ISO 62304

One of our strong points is our experience with the development of custom software and hardware projects. Such know-how is invaluable especially when it comes to developing software for medical applications. Our quality management has been approved since 2005 for the development of medical devices and their software according to EN ISO 13485. We are happy to share the know-how from this experience with our customers.
We assist you in turning your ideas for medical software into a software project developed along the guidelines of ISO 62304, making the process safe and reliable. Whether you need the whole package or just parts of it, we lead or guide your project - step by the step - from first draft to specification, software design, implementation, validation and finally approval as medical software.

Consultation
  • Discussion of your ideas, drafts and concepts
  • Evaluation of all requirements and costs
  • Evaluation of risk class
  • If needed: Support establishing a quality management system according to EN ISO 13485
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Development
  • Drafting a software development plan
  • Risk analysis/ risk management according to ISO 14971
  • Software specification and software architecture with focus on usability according to DIN EN 62366
  • Development and implementation of algorithms
  • Validation
  • Technical documentation for medical software
Pfeil zum nächsten Modul
Configuration management/ updates
  • Source code management
  • software updates
Pfeil zum nächsten Modul
Guidance through the certification process
  • Support during the certification process
  • Help with necessary documentation and papers
  • Providing traceability of the whole software lifecycle
Begriffe aus dem Qualitätsmanagement Medizinsoftware

Why AXIOS 3D Services?

  • Long experience with the development of
    software and software components
    in medical applications
  • Certified according to DIN EN 13485 (since 2005)
  • Developer and distributor of medical devices
    (Certificate of conformity 93/42/EWG, Appendix 2)
  • Software developers and quality engineers with
    years of experience developing
    medical software

You decide, how much and which service
you need:

  • Support through all necessary steps
    for medical software according to
    Medical device guideline 93/42/EWG
  • Development of algorithms, software libraries et cetera
  • Complete development and documentation
    of the software project
  • Guidance up to certification

We are happy to provide you with
further information and quotations.
Please contact us!