Question
Hi,I wonder if there is someone in here who knows of a standard which includes a symbol that conveys "reclosable packaging"? I have only seen such symbols on food containers, but do you know or think it would be possible also on a medical device cont...
This particular question seems to be a common nonconformity during audits. There are three reasons for this:the question is on several regulatory checklists for certification bodies,training on regulatory requirements is seldom provided to design eng...
Don’t ever believe what you hear. Instead, look it up. I think the software requirements are minimal in the newly released ISO 13485:2016 standard, but other experts disagree. In the QSR, software is also covered, and regulatory requirements are incl...
Recently I received an email inquiry from a LinkedIn group member that asked about the appropriate inspection requirements and operator certification for soldering electronic components to a printed circuit board for medical devices.The ISO 13485 Sta...
What will the regulators do in response to the 2016 changes?How do we revise our supplier controls?When will the standard be harmonized with the EU directives?In one of my previous announcements a couple of people responded to my announcement indicat...
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...
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...
