Hi guys,
I hope someone here can help me. I'm new to QA and medical device field. I'm trying to doc control IFU and was wondering if you need to doc control the design/formatting or just the content? The company I'm working for had the IFU designed on Vista print so I can't download down a modifiable document. Would it be acceptable to doc control a PDF (which the file can be download down as)? The company made custom made medical device hence they are somewhat under TGA radar and is trying to obtain ISO13485 cert.
Any inputs will be much appreciated.
I hope someone here can help me. I'm new to QA and medical device field. I'm trying to doc control IFU and was wondering if you need to doc control the design/formatting or just the content? The company I'm working for had the IFU designed on Vista print so I can't download down a modifiable document. Would it be acceptable to doc control a PDF (which the file can be download down as)? The company made custom made medical device hence they are somewhat under TGA radar and is trying to obtain ISO13485 cert.
Any inputs will be much appreciated.