Andy, Please note I had made assumptions that (clear in my response), much in the same way that you assume that none exists for the issue at...
Hi All, I have been told to include that this is about a medical device otherwise it can cause confusion, but I am not able to edit the original...
Andy, both ISO 13485 [(2003 clause 8.5.2)(2016 clause 8.7 and 10.2)] and 21 CFR 820 (subpart J) reference noncomformities but do not define...
Here is a fun dilemma for all: Where a country is a principality, like Monaco is of France, does one reference France as the country in the "Made...
For me this would be an internal non-conformance and a major one at that for the following reasons: if there is a procedure for pulling names and...
Hi All, I wonder if anyone else has this logistic issue that they may have found a solution to, add they could share? My company currently...
Yes - we do as we are annex II. Thanks for clarifying. Fialor
Hi All, My company is in the process of registering a medical device in Russia and the distributor/partner is asking for essentially the entire...
Hi Everyone My company is beginning to place class IIa and IIb devices on the EU market and we are based in the UK as a UK manufacturer. Do I...
Hi All, I am a novice when it comes to the use of RF technology on porducts. The product I am working on intends to have RF to prevent re-use...
Hi MarkMeer, I just joined and read this so it might be a little too late - but the USA does have a Human Factors guidance document that is quite...
Hi All, I am hoping I can get an explanation on an issue I am having with an external test house: I provided a product for testing to EN IEC...
Separate names with a comma.