CharleyBarks
Computer
Hi,
I‘m working for IT company. We produce the software for medical devices.
I’m trying to find out which clause of ISO 13485 covers control of the development and test environment that we establish during software product development and testing. Is it p. 6.4 Work Environment or some of the clauses in section 7 Product realization?
I‘m working for IT company. We produce the software for medical devices.
I’m trying to find out which clause of ISO 13485 covers control of the development and test environment that we establish during software product development and testing. Is it p. 6.4 Work Environment or some of the clauses in section 7 Product realization?
