Question
Does anyone know if there is a standard to detect counterfeit parts from entering your supply chain when purchasing from an Independent Distributor due to obsolescence?source: https://www.linkedin.com/groups/2070960/2070960-6115363616561651715
Does anyone have the list of the COFEPRIS approved TPRs? Thanks in advance!source: https://www.linkedin.com/groups/2070960/2070960-6109166341242056708
If the company is OBL (orginal brand label) and does not have own iso 13485 certificate can register products in Australia (and be "legal manufacturer)? I should mention that OEM (orginal equipment manufacury) owns iso 13485 certificate so these prod...
After watching this release get pushed back quarter after quarter for longer than some documents exist, does anyone in the group have any visibility on when ISO13485:2016 (2017?) is actually likely to be released. Or even what the review status of th...
A client of mine recently received a FDA Form 483 with multiple inspection observations and they wanted to know how to prioritize their corrective actions. Typically companies will work on corrective actions for each 483 observation in parallel. Howe...
Dear all,For devices of similar indications as product code KNW (Gastroenterology-urology biopsy instrument), several microbiology testing labs have mentioned that 3 samples is sufficient for sterilization and cleaning efficacy validation for a 510(k...
I have received a request regarding legalization of documents that I could use some guidance on. The request originates from Mexico, asking that an ISO cert for an OEM be legalized either 1) in the originating country of the certificate issuer or 2) ...
The best regulatory affairs managers review guidance documents and quickly identify which elements are most important and will require the most amount of time. These elements are prioritized first for a regulatory submission project.In last week’s bl...
Companies developing devices with truly innovative technologies frequently have difficulty identifying suitable predicate devices. The best regulatory experts plan in advance for these regulatory submissions by honing their knowledge of the De Novo a...
source: https://www.linkedin.com/groups/2070960/2070960-6095219699472220163
