Thomas Regulatory
@raqaconsulting
Medical Device Regulatory Affairs & Quality Management Systems Audit Consulting FDA 483 Warning Letter CER Clinical Evaluation 510K, 510(k) ISO 13485 21 CFR 820
ID: 921156453053943808
http://thomasregulatory.com 19-10-2017 23:29:47
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“In #medtech #medicaldevice industry it must start with why we do what we do.” --Dennis Hahn. Powerful #MedCon 2018 opener video on Operation Smile see ow.ly/buvy30jNc3O Xavier Health #regulatoryaffairs #quality #FDA #ISO13485 We must do it for the right reasons.
Thanks for the mention! BizForBreakfast: RT Thomas Regulatory: "I’m a big fan of small #business ownership. I think it’s the backbone of American innovation. But to be successful you first have to have the #courage to go for it. "– Bill Rancic, #Entreprene…
Because some #manufacturers were not taking seriously to make safe & effective #medicaldevices #FDA has to do it’s part in #enforcementaction to protect #publichealth & takes it seriously --Thoughts fr Leadership of FDA office of #regulatoryaffairs at #MedCon 2018 Xavier Health
#MedCon Panel introducing the exciting world of #artificialintelligence in both #medicaldevice products as well as #manufacturing processes & introducing new concept #GmLP Mac McKeen Xavier Health #FDA #regulatoryaffairs #ai #digitalhealth #gmp #iso13485 #medtech #quality
#MedCon 2018 all #FDA panel is very clear that #humanfactors and #usability #engineering is applicable to all #medicaldevices & not optional & the need for #medtech industry to provide evidence & data w/ integrity on this topic is critical Xavier Health FDA/CDRH Industry U.S. FDA
"It would take some time. It is not a short process. It is not going to be a fast process. It would be noble in cause, but a lot – a lot – of work," NSF 's Kim Trautman says about U.S. FDA considering replacing Quality System Regulation w/ #ISO 13485 medtech.pharmaintelligence.informa.com/MT122610/ByeBy…