Hello Anon, There can be multiple names of companies on the product labelling, more specifically two company names on the device label, but it needs to be clearly identified who is the (legal) Manufacturer read more
Hello, No, you are not and there should be a reference to standards used for symbols - which would generally be ISO 15223-1. ------------------------------ Richard Vincins ASQ-CQA, MTOPRA, RAC Vice President read more
To clarify my response, I meant that if your device was undergoing NB review anyway (had to have NB involvement), they would certainly look at your RED compliance evidence and expect to see it on the DoC. read more
Dear Anon, This is an easy task for SOFIE, our Regulatory Intelligence database. Let me know what product code(s) you are looking for and I can run a report for you. cheers, Melissa ------------------------------ read more
Apart from the requirements, which other have covered, I think that following all the requirements, especially design controls, results in a better product and is therefore better for your business. Especially read more
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This message was posted by a user wishing to remain anonymous Colleagues, Does anyone have a recommendation for one or more resources (eg, courses, webinars) that can be used to gain a more comprehensive understanding of US statutes and regulations ...
This message was posted by a user wishing to remain anonymous Hi, Can someone share a slide deck for Risk-based Scenario Planning with Time Horizon? TIA
This message was posted by a user wishing to remain anonymous For foreign manufacturers, does PMDA conduct unannounced inspections? For new device registration (Shonin), does PMDA conduct a pre-market approval inspection or will they accept the MDSAP ...
This message was posted by a user wishing to remain anonymous Hello, I would appreciate feedback as to whether allowing compatibility between two licensed knee systems would required a significant amendment to be submitted to Health Canada. There ...
This message was posted by a user wishing to remain anonymous Hi, If I have an IVD assay that went thorough the 510k process and got cleared with general instrument. What are the requirements if I need to tie it to a certain instrument? What are all ...
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