mdr-745-specialist
alirezarezvani736 installs
Plan your medical device's EU MDR compliance.
What it does
Develops medical-device compliance assessments and documentation plans for EU MDR.
When to use it
Use for device classification, technical-file preparation or gap checks, clinical evaluation and surveillance planning, or notified body review preparation.
How to use it
Give it a medical-device compliance question; it returns classification guidance, documentation requirements, or compliance planning recommendations.
Uses
EU
Latest review
What you need · 1
Python 3 enables the bundled gap-analysis tool.
Access · 2
This skill
EUDAMED
Write
Registers actors and devices in EUDAMED
clinical literature
Read
Searches clinical literature