Hi all, we are new medical device startup based in New Zealand. We are currently only planning to sell in New Zealand and want to enter the Australian markets maybe next year. We are planning to get our ISO:13485 and I had a few questions.
1. We are planning to exclude design from the scope and wondering if we would still require a DHF? NZ has no recommended regulatory requirements as such.
2. My understanding is that we essentially require a Device Master Record and Device History Record which can become our medical device file.
Is my thinking, right? or am I missing something here?
1. We are planning to exclude design from the scope and wondering if we would still require a DHF? NZ has no recommended regulatory requirements as such.
2. My understanding is that we essentially require a Device Master Record and Device History Record which can become our medical device file.
Is my thinking, right? or am I missing something here?