Studio
Custom medical device software development
Your technology, your clinical protocol, your specifications. We design the solution, assemble our existing building blocks and develop what's missing, under our quality system.
How a custom development works
Four steps to develop custom Software as a medical Device
Studio designs your solution and draws on the technologies your project requires. A custom project doesn't start with code: it starts by checking that the input data matches the real need, and that the regulatory requirements are set from the outset.
- 01
Your needs
You describe the surgical procedure, the associated digital workflow, what you have already built and what you expect in the operating room. We assess feasibility and the targeted regulatory class.
- 02
Scoping offer
When your requirements are already specified, we move straight to development. Otherwise, the scoping phase lays the foundations of the project. We then send you a scoping proposal.
- 03
Scoping if needed
A short, fixed-scope series of workshops, with no obligation to continue with OneOrtho Medical for the subsequent development.
- 04
Development
Two tracks run in parallel, with verification and validation carried out in parallel under our quality system.
Integration of existing assetsCustom developmentV&V
Scoping: where a project takes shape.
Its aim is to lay solid foundations to deliver the project efficiently. It's a short engagement, with defined deliverables that remain your property even if you don't continue with us.
Explore OneOrtho Medical's manufacturer status- Input data that truly matches the need
- The right technology choices
- A reliable budget and schedule
- Regulatory requirements and the business plan taken into account from the start
- Deliverables directly usable for what comes next: project plan, input data, functional specifications
Your project needs something that doesn't exist yet?
Describe the procedure and the imaging you have. Scoping starts there.
Let's discuss your project
