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Ritam, No one mentioned Commission Regulation (EU) 207/2012--i.e. on electronic instructions for use of medical devices; see link below, in case it is helpful to you.  https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:072:0028:0031:en:PDF  When we converted to electronic labeling ...

Hi, I am not an expert.  I thought there was a table for sampling in a standard; however, I could not find it.  Here's what I found, "In most cases, determination of sample size is left for each company to decide and justify following a statistically valid rationale (reference ISO 11607-1, Section ...

Hi, Based on the October 2017 guidance, a risk-base assessment of the labeling changes should be completed.  Are "new risks or significantly modified existing risks" identified based on the manufacturer adding warnings and storage conditions?  If Yes, based on the guidance a new 510(k) is required.  ...

No, I believe it means the outside package must have the EO symbol on it or an indicator that the device inside is provided sterile.  ISO 15223-1 includes the EO sterilization symbol.  The importer just checks the outside of the box. Kind regards, ------------------------------ Alyssa Thomas RAC ...