2009年7月13日 · Thank you very much. So I have to get FDA approval on the products. As a marketer I have to get registration and product listing as well as under QSR820's control.However,I am a trading company, but my contract manufacter under ISO13485 control.

2010年10月28日 · Hi, fellow cove dwellers, My company is a medical device company and we're setting up systems in preparation for ISO 13485 certification and conformance to...

2009年4月16日 · QSR820 has a special requirement about the labeling and the packaging control, that is, the requirement about the label integrity, label inspection, label storage and label operation. I think ISO13485 does not have a clear requirement about this, and QSR820 require us to establish a labeling and packaging control procedure.

2012年6月18日 · I'm very puzzled about the setcion 820.90 of FDA 21CFR QSR820, Do you have a full understading about this section that could share with me? I have several questions as below: 1: "The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the ...

2009年9月7日 · However, usually there are many design phases in the development cycle. And the design output of one phase is the design input of the next phase. It is just like a cycle. So i think there is no clear difference between "design input" and "design output". But it is sure there is a definition of "desin input" in QSR820.

2009年4月15日 · Hi everyone, when i was reading the QSR820's manual downloaded from FDA's website, especially the chapter 9 of " document and change control", i found that FDA had attached a template of change control procedure. I think this procedure is a combination of the 3 procedures, that is, the design...