ND Global(@GlobalNd54657) 's Twitter Profile Photo

'Looking to navigate the FDA's Pre-Submission Program for medical devices and IVDs? Our experienced US consulting team can guide you through this critical step toward FDA clearance.
Follow us at: ND Global
'

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The Tao of Excellence(@taoexcellence) 's Twitter Profile Photo

The has released Revision 1 of the guidance document MDCG 2022-9, outlining changes to the Summary of Safety and Performance template for . 1/5
health.ec.europa.eu/document/downl…

The #MDCG has released Revision 1 of the guidance document MDCG 2022-9, outlining changes to the Summary of Safety and Performance #SSP template for #IVDs. 1/5
health.ec.europa.eu/document/downl…
#IVDR #MedicalDevices #RegulatoryCompliance #HealthcareInnovation #PatientSafety #EUDAMED
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h ⋆ ˚。⋆౨ৎ˚(@oceanbIvds) 's Twitter Profile Photo

ticketmaster knew what they were doing not giving me presale cause i would’ve been the most annoying person ever

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Psephos Biomedica(@PsephosBio) 's Twitter Profile Photo

Psephos’ Robin Stephens will be a speaker at The 3rd Conference on Clinical Studies with Medical Devices and IVDs ( ), 29-30 May 2024 @ Hilton London Canary Wharf. Register here: csmd2024.com/registration/

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H-Metro(@HMetro_) 's Twitter Profile Photo

This follows concerns that there is a proliferation of substandard and counterfeit IVDs in the country.

hmetro.co.zw/pregnancy-hiv-…

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Nyasha B(@iamnyashab) 's Twitter Profile Photo

Was delighted to be a part of the stakeholders meeting to deliberate In Vitro Diagnostic (IVD) Medical Devices Draft Regulations. Quality and performance of IVDs play an important part in patient care and health outcomes. The draft regs are certainly an important step in health

Was delighted to be a part of the stakeholders meeting to deliberate In Vitro Diagnostic (IVD) Medical Devices Draft Regulations. Quality and performance of IVDs play an important part in patient care and health outcomes. The draft regs are certainly an important step in health
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Clinical Lab Products Magazine(@CLPmag) 's Twitter Profile Photo

The U.S. FDA finalized a rule regarding its oversight of LDTs to make explicit that IVDs are considered devices under the FD&C Act. Read here: buff.ly/4dgWxa5 s

The U.S. FDA finalized a rule regarding its oversight of LDTs to make explicit that IVDs are considered devices under the FD&C Act. Read here: buff.ly/4dgWxa5 #fda #ldt #ldts #labdevelopedtests #IVD
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FDA Medical Devices(@FDADeviceInfo) 's Twitter Profile Photo

Today the U.S. FDA issued the following draft guidances about enforcement discretion for certain IVDs in response to emergencies and public health threats.

Today the @US_FDA issued the following draft guidances about enforcement discretion for certain IVDs in response to emergencies and public health threats.
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The Tao of Excellence(@taoexcellence) 's Twitter Profile Photo

For sponsors of performance studies for in s in the . The published a new guidance regarding safety reporting in performance studies of IVDs R . 1/6
health.ec.europa.eu/document/downl…
Regulation

For sponsors of performance studies for in #IVDs in the #EU. The #MDCG published a new guidance regarding safety reporting in performance studies of IVDs #IVDR. 1/6
health.ec.europa.eu/document/downl…
#IVD #PMPF #SafetyReporting #EURegulation #SAE #invitrodiagnostics
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Nyasha B(@iamnyashab) 's Twitter Profile Photo

regulation and advancing health care standards in Zimbabwe. If the regulations go through, this will lead to regulation of manufacturers, wholesalers and distributors of IVDs.

Medical Devices are regulated in other territories & theres a use of a risk classification system

regulation and advancing health care standards in Zimbabwe. If the regulations go through, this will lead to regulation of manufacturers, wholesalers and distributors of IVDs. 

Medical Devices are regulated in other territories & theres a use of a risk classification system
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Compliance & Risks(@ComplianceRisks) 's Twitter Profile Photo

Brazil's Resolution RDC No. 848 is set to elevate the quality of medical technology bringing significant changes to safety and performance requirements.

Dive into the details with our latest blog: bit.ly/3Q8OD91

Brazil's Resolution RDC No. 848 is set to elevate the quality of medical technology bringing significant changes to safety and performance requirements. 

Dive into the details with our latest blog: bit.ly/3Q8OD91

#MedicalDevices #IVDs #Regulations #Brazil
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