regtrac's profile picture. RegTrac is a trusted Regulatory Partner for navigating the complex landscape of Global Regulatory Affairs, Quality Systems and Compliance, with expert guidance.

RegTrac

@regtrac

RegTrac is a trusted Regulatory Partner for navigating the complex landscape of Global Regulatory Affairs, Quality Systems and Compliance, with expert guidance.

Day 2️⃣ at @Arab_Health: Today was all about bringing #connections to life! Transforming conversations from #2D to #3D! Pleasure to cross paths with @SYNDEOMedical, a visionary #partner in the #healthcare industry. #ArabHealth #medicaldevices

regtrac's tweet image. Day 2️⃣ at @Arab_Health:

Today was all about bringing #connections to life! Transforming conversations from #2D to #3D!

Pleasure to cross paths with @SYNDEOMedical, a visionary #partner in the #healthcare industry. 

#ArabHealth #medicaldevices

Are you at @Arab_Health? Then you know navigating the halls ain't easy! Nevertheless, @regtrac can make #regulatory navigation easy for you. 😉 Grab & tag one of our experts @NishaVempalle and @coolmonideepa to get a #freebie! 🥏 #Dubai #ArabHealth2025 #ArabHealth #AH


RegTrac reposted

Danke, @MEDICATradeFair 2024! ✨ RegTrac participated in the biggest healthcare event in #Düsseldorf this week; Dr Nisha Vempalle engaged with #pioneers and #leaders shaping the future of #healthcare across the #globe.



Danke, @MEDICATradeFair 2024! ✨ RegTrac participated in the biggest healthcare event in #Düsseldorf this week; Dr Nisha Vempalle engaged with #pioneers and #leaders shaping the future of #healthcare across the #globe.


@regtrac is attending #MEDICA - Dusseldorf, Đức 2024! Let's explore your regulatory goals and how @regtrac can support your #compliance strategy as a valued #partner. 👉Reserve your spot by booking a meeting now: lnkd.in/g2rcp3nu #Medica2024 #Healthcare #MedTech


🎉 Exciting news at @regtrac! We are thrilled to welcome Dr Nisha Vempalle as our Vice President. With her expertise and vision, we look forward to elevating our commitment to excellence in regulatory affairs! #RegTrac #Welcome #Leadership

regtrac's tweet image. 🎉 Exciting news at @regtrac!

We are thrilled to welcome Dr Nisha Vempalle as our Vice President. With her expertise and vision, we look forward to elevating our commitment to excellence in regulatory affairs!

#RegTrac #Welcome #Leadership

Another very happy #MedTech client for our recent #ISO13485 and #EUMDR compliance QMS project completed in record 3 weeks time. With the deadline of May 2025 for IVDR-compliant #QMS implementation, reach us today at reg-trac.com to discuss your QMS requirements.

regtrac's tweet image. Another very happy #MedTech client for our recent #ISO13485 and #EUMDR compliance QMS project completed in record 3 weeks time. 

With the deadline of May 2025 for IVDR-compliant #QMS implementation, reach us today at reg-trac.com to discuss your QMS requirements.

IEC 62304:2006 establishes a #commonframework for medical device #SoftwareLifeCycle. @regtrac offers #QMS & #regulatory services for #medicaldevices & other #healthcare products. Book a 30 min dialogue with our experts at [email protected] | reg-trac.com


ISO 8637-3:2018 specifies #acceptancecriteria for #safety parameters of #plasmafilters. @regtrac offers #QMS & #regulatory services for #medicaldevices & other #healthcare products. Book a 30 min dialogue with our experts at [email protected] | reg-trac.com


ISO 18562-1:2024 describes #biocompatibility of #medicaldevices with a #GasPathway. @regtrac offers #QMS & #regulatory services for #medicaldevices & other #healthcare products. Book a 30 min dialogue with our experts at [email protected] | reg-trac.com


ISO 15198:2004 describes a process to validate #QualityControl procedures shared with users. @regtrac offers #QMS & #regulatory services for #invitrodiagnostics & other #healthcare products. Book a 30 min dialogue with our experts at [email protected] | reg-trac.com


ISO 14644-16:2019 describes #EnergyUsage optimization in new and existing #cleanrooms. @regtrac offers #QMS & #regulatory services for #medicaldevices & other #healthcare products. Book a 30 min dialogue with our experts at [email protected] | reg-trac.com


ISO 8600-3:2019 describes #TestMethods for #FieldOfView and #DirectionOfView of #endoscopes. @regtrac offers #QMS & #regulatory services for #medicaldevices & other #healthcare products. Book a 30 min dialogue with our experts at [email protected] | reg-trac.com


ISO 8600-5:2020 provides a #measurement method for characterizing a rigid #endoscope image. @regtrac offers #QMS & #regulatory services for #medicaldevices & other #healthcare products. Book a 30 min dialogue with our experts at [email protected] | reg-trac.com


ISO 15223-1:2021 has a symbol to denote #medicaldevices that have been sterilized by H2O2. @regtrac offers #QMS & #regulatory services for #medicaldevices & other #healthcare products. Book a 30 min dialogue with our experts at [email protected] | reg-trac.com


ISO 21474-1:2020 describes #qualitative and #quantitative #NucleicAcid sequence detection. @regtrac offers #QMS & #regulatory services for #invitrodiagnostics & other #healthcare products. Book a 30 min dialogue with our experts at [email protected] | reg-trac.com


This ISO 15223-1 symbol indicates the presence of a #SterileFluidPath in a medical device. @regtrac offers #QMS & #regulatory services for #medicaldevices & other #healthcare products. Book a 30 min dialogue with our experts at [email protected] | reg-trac.com


ISO 23450:2021 specifies #TestMethods, #InstructionsForUse & #marking for intraoral cameras. @regtrac offers #QMS & #regulatory services for #medicaldevices & other #healthcare products. Book a 30 min dialogue with our experts at [email protected] | reg-trac.com


The symbol "Non-sterile" denotes that the #medicaldevices are not subjected to #sterilization. @regtrac offers #QMS & #regulatory services for #medicaldevices & other #healthcare products. Book a 30 min dialogue with our experts at [email protected] | reg-trac.com


ISO 18250-6:2019 specifies the #connectors for neural reservoirs and neural giving sets. @regtrac offers #QMS & #regulatory services for #medicaldevices & other #healthcare products. Book a 30 min dialogue with our experts at [email protected] | reg-trac.com


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