🦠 In our recent #ExpertInsights article, our VP of Clinical Research delves into the FDA's recent decision to reclassify certain #infectiousdisease #IVDs from Class III to Class II.
hubs.ly/Q02ryqNq0
#DCNDx #FDA #Regulatory #ClinicalStudies #Diagnostics
'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
#FDA #MedicalDevices #IVD #RegulatoryCompliance '
The reagents and consumables segment holds a significant market share, surpassing 65% in the Europe in-vitro diagnostics (IVDs) market.
Know more ow.ly/s9Ge50RmTc8
#europeinvitrodiagnosticsmarket #invitrodiagnosticsmarket #ariztonresearchreveals #focusreportsbyarizton
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
Psephos’ Robin Stephens will be a speaker at The 3rd Conference on Clinical Studies with Medical Devices and IVDs ( #CSMD2024 ), 29-30 May 2024 @ Hilton London Canary Wharf. Register here: csmd2024.com/registration/
#clinicalstudies #regulatorycompliance
🦠 In our recent #ExpertInsights article, our VP of Clinical Research delves into the FDA's recent decision to reclassify certain #infectiousdisease #IVDs from Class III to Class II.
hubs.ly/Q02ryyYN0
#DCNDx #FDA #Regulatory #ClinicalStudies #Diagnostics
🦠 In our recent #ExpertInsights article, our VP of Clinical Research delves into the FDA's recent decision to reclassify certain #infectiousdisease #IVDs from Class III to Class II.
hubs.ly/Q02ryrRM0
#DCNDx #FDA #Regulatory #ClinicalStudies #Diagnostics
Final Rule Declares IVDs to Be Devices Regulated by the FDA dlvr.it/T6BGm8 #fda #financial #lifesciences
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