Thomas Regulatory

Medical Device Regulatory Affairs & Quality Management Systems Audit Consulting FDA 483 Warning Letter CER Clinical Evaluation 510K, 510(k) ISO 13485 21 CFR 820

[Fuck this shit I’m outta here @fuckTwatter6666]

US FDA Commissioner Scott Gottlieb wrote in a May 9 blog post that the agency will propose a new rule that will blend its Quality System Regulation with international quality systems standard ISO 13485 https://t.co/ugGSJBeUrX

[Fuck this shit I’m outta here @fuckTwatter6666]

"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_Intl 's Kim Trautman says about @US_FDA considering replacing Quality System Regulation w/ #ISO 13485 https://t.co/oiSDWzTmJK

[Fuck this shit I’m outta here @fuckTwatter6666]

Chasing Quality Isn't Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites https://t.co/IpdM9T6tgu

[Fuck this shit I’m outta here @fuckTwatter6666]

#FDA wants to swap its Quality System Regulation for ISO 13485 'in the coming years,' agency official says at #MedCon https://t.co/DyaE78QZL2

[Thomas Regulatory @RegulatoryThom]

“In #medtech #medicaldevice industry it must start with why we do what we do.” --Dennis Hahn. Powerful #MedCon 2018 opener video on @operationsmile see https://t.co/oNRjqzgQTO @XavierHealth1 #regulatoryaffairs #quality #FDA #ISO13485 We must do it for the right reasons.

[Thomas Regulatory @RegulatoryThom]

Thanks for the mention! BizForBreakfast: RT @RegulatoryThom: "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…

[Thomas Regulatory @RegulatoryThom]

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 @XavierHealth1

[Thomas Regulatory @RegulatoryThom]

#MedCon Panel introducing the exciting world of #artificialintelligence in both #medicaldevice products as well as #manufacturing processes & introducing new concept #GmLP @mckeen_mac @XavierHealth1 #FDA #regulatoryaffairs #ai #digitalhealth #gmp #iso13485 #medtech #quality

[Thomas Regulatory @RegulatoryThom]

#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 @XavierHealth1 @FDAcdrhIndustry @US_FDA

[Thomas Regulatory @raqaconsulting]

#mdtxevent #MDTX Dr. Michael Drues discussion on labeling.

[Thomas Regulatory @raqaconsulting]

#mdtxevent #MDTX

[Thomas Regulatory @RegulatoryThom]

@FloridaMedTech hosting exec briefing 2 Nov in Boca Raton 4 medical device professionals 4 transition ISO 13485:2016 https://t.co/918Jes42SD