How do you ensure the Tractability?

Where are you maintain the traceability?

Do u have unit testing capability for the customer provided Code?
Reverse engineering ?
Do u have certified test facility?
Reliability Testing?

Tools used for reliability testing?
Do u perform sterilization testing?
During mehc verification strategy and Test Plans are prepared by customer or You?
Who has indetified the test methods?
How large is your test facility ? 9000 sft, 7000 sft + 2000 sft
In mech:
What type of pump testing is performed?
How did u decide on sampling criteria?
DO u inject failures during chamber testing?
Electrical engineers in Medical :40
Are you maintaining the design history file?
What are the challenge you faced in verifications?
Do u have capability to perform clainical trails?
ECG, Pulse Oxo meter? ( Heamnt)