Medical Robot Standards and Approval
The route
| Stage | Requirement |
|---|---|
| Classification | Determine the regulatory category of the device |
| Quality system | Certified manufacturing and design controls |
| Testing | Type testing to applicable standards |
| Clinical evaluation | Evidence of safety and performance |
| Registration | Approval before sale |
Consequences for development
Changes after approval are expensive, so design decisions and documentation must anticipate regulatory review from the start. Timelines are measured in years, not quarters.