IVD & medical software development

Get audit-ready software with exceptional user experience.

Alifax
Cytena
GeneFirst

Move your project from a concept stage into realization

Icon darts

Faster

Bring your IVD medical device to the market faster.

Icon darts

Less costs

Reduce the costs of your IVD software project.

Icon darts

UX design

Improve user adoption with great user experience design.

Icon darts

Documentation

Have all documentation ready for regulatory authorities.

Icon darts

Expertise

Work with our interdisciplinary team with a proven track record.

Watch our webinar: How to implement 21 CFR Part 11 features into your software

How to implement 21 CFR Part 11 features into your software

Recently we hosted a webinar on the topic “How to implement 21 CFR Part 11 features into your software“.

Watch the webinar to discover:

      Expert advice on practical implementation

      Examples from the industry

      Answered questions from the audience

Bring high-quality laboratory software to the market faster

Tablet with PlatR software

Expert software and documentation

  • ISO 13485, IEC 62304, GxP and FDA’s 21 CFR Part 11 standards and regulations.
  • Audit-ready software-related documentation.
  • Well-established QA processes and software validation.
  • Extensive unit tests for software verification.
  • Software for diagnostics and RUO (research use only).
Tablet with PlatR software
featured image

UX design that focuses on enchaced usability

  • Great UX on top of the uncompromising safety and effectiveness.
  • Intuitive UX design for improved user adoption.
  • UX as an important selling point and competitive advantage.
  • Integration of UX in the complete software development cycle for reduced time to market.
Listeners

Professional and reliable partner

  • Over 90 products launched in the last decade.
  • Experienced project managers with a proven track record.
  • Application specialists with years of experience in the diagnostic laboratories, understanding of the essentials of working at the bench.
  • Extensive experience in software-hardware integrations and standardization that enable interoperability.
Listeners

Quality assurance

Icon

Quality management system

ISO 13485

Icon

Regulations implementation

IEC 62304, GxP requirements and implementation of FDA’s 21 CFR Part 11 features

Icon

Medical device regulations

EU IVD, US FDA, UK MDR 2002

 Learn more about our way of working

Discover more about IVD medical device sofware development and regulations

Download the article and learn more about:
   Regulations and standards for IVD medical devices
   7 steps of software development life cycle
   What you gain when outsourcing software development for IVD medical devices

Are you planning a new IVD software project?

Send us a message and speak with our experts.