Consulting and Project Support
Would you like to develop a medical app, a digital healthcare service or an e-health service, but don’t know what you need to get started? We will assist you in planning, designing and implementing compliant projects, and we will guide you throughout the entire software life cycle.
Due to our quality management system to EN ISO 13485 standard, we can develop compliant software that is analogous to a medical device, or take on an advisory role while you do the development.
We frequently have to clarify very fundamental questions, such as the following.
Is my software a medical device?
We would be happy to assist you in evaluating your product or service, and to formulate together with you an intended purpose that suits your objective.
What should I keep in mind when developing software as a medical device?
The abundance of directives for quality management (EN ISO 13485), risk management (EN ISO 14971), requirements and usability, and the software life cycle (EN IEC 62304), and the resulting paperwork and obligations can seem overwhelming. Don’t be discouraged by this! The harmonized standards are the means to the successful completion of a medical-device project. We will help you to break down the requirements and tasks into easy-to-achieve interim objectives and ultimately to complete the entire project successfully.
Procedures for documentation in the context of quality assurance
in accordance with MDD/MDR and FDA CFR requirements
However, we can do a lot more than just consulting: we would be happy to develop your software project in a manner that is compliant with standards and the law. This applies to the development of both CE-compliant software and non-medical devices.
Learn more about software development as a medical device...
Do you have any questions?
Then get in touch with us! We would be happy to help you.