Diagnostic Biomedical Device Design

I am in the middle of creating a new piece of biomedical instrumentation and need a partner who can take the lead on design and development.
The immediate priority is a diagnostic device, so we will be working through system architecture, sensor selection, analogue front-end design, embedded firmware and the mechanics that bring it all together. A second stream of the project covers a physical-therapy therapeutic module that will share portions of the same electronics and software stack, so decisions we make now should keep that expansion in mind.

You will have room to drive the schematics, PCB layout, firmware structure and risk-management documentation while keeping us on a clear path toward IEC 60601 and ISO 14971 compliance. I will supply the clinical workflow, performance targets and any existing bench data; you translate that into a working prototype ready for internal testing and, later, formal validation.

Deliverables
• Complete design package: schematics, PCB gerbers, BOM and enclosure model
• Compiled and well-commented firmware source with build instructions
• Prototype build guide and test report showing the device meets the agreed diagnostic accuracy and safety limits
• Short technical memo outlining how the architecture can be extended to the upcoming physical-therapy module

Acceptance criteria
The prototype must operate within the stated accuracy band, pass basic electrical safety checks and be reproducible from the documents provided.