What to prepare
Bring the clinical need, intended users, use environment and technical constraints. Describe existing prototypes, background intellectual property and evaluation resources.
← Capabilities
Biomedical Engineering and Devices
Translate healthcare needs into specifications, prototypes, evaluation and responsible evidence.
Discuss this capability →microscopIA
Possible deliverables
Planning examples, not a fixed package. The written scope defines the work, team, resources and timeline.
An intended-use statement and traceable technical requirements.
A prototype or engineering work package, with a defined verification plan.
A test report, usability considerations and an evidence-development roadmap.
Interpretation and boundaries
A prototype is a development output, not an approved medical device. Manufacturing, clinical evaluation and market authorization are separate workstreams.
Explore a use case
- Imaging devices
- Screening systems
- Clinical technologies
- Technical requirements
- Usability
- Clinical evaluation
- Regulatory planning