Medical software development and regulation

Outsourcing medical software development

We have a solid experience in the product development process for creating medical software. Our software developers and project managers know how to create medical apps and other software solutions that are not only functional, but also compliant with the regulations and standards.

In addition to software development, we provide outsourced project managers and head of development as service. We also create proofs of concepts. We assist you in charting, introducing and configuring the required development tools, and ensure project progress according to plan and on schedule.

Medical applications compliant with regulations

Our project managers are responsible for following the international standards and other regulations specifying life cycle requirements for the development of medical software. We have dedicated in-house teams who work with quality management systems (QMS), regulatory affairs and data management. This allows effective production cycle, as ensuring compliance with MDR and other applicable standards and regulations is among our core capabilities. 

Regulatory Planning

We have expertise in regulatory planning for different markets, including the EU, FDA, and other regions, ensuring your products meet all the requirements. Our team can assist you in defining and documenting software requirements, ensuring your systems fulfill usability requirements, are compliant, and meet medical electrical standards.

Product Development Health Check

Product development health check allows you to ensure that the project is appropriate and fulfils requirements and you have sufficient resources and the right tools and methods for completing your project successfully.

Product development health check is a light, audit-like preliminary evaluation that involves examining the current state of your product development in relation to the requirements set by the medical device software – Software life-cycle processes standard (EN 62304:2006). The service is highly beneficial, for instance, when a software company that has already established its presence expands its operations to medical software.

Detailed plan for executing medical software development project

After thoroughly familiarising with your project and reviewing the development documentation, we will provide a list of observations and draw up a plan of measures and a schedule for correcting any deviations and failings that may have been detected.