RegTrac

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

[RegTrac @regtrac]

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 @regtrac]

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

[Adarsh Anand @_AddyAnand]

#Medica 2024 was a hit!

#healthcare #medicaldevices #invitrodiagnostics

[RegTrac @regtrac]

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 @regtrac]

@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: https://t.co/6Nl9tdsPIZ

#Medica2024 #Healthcare #MedTech

[RegTrac @regtrac]

🎉 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 @regtrac]

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 https://t.co/o13g7dcpqU to discuss your QMS requirements.

[RegTrac @regtrac]

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] | https://t.co/fRviKmkmgn

[RegTrac @regtrac]

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] | https://t.co/fRviKmkmgn

[RegTrac @regtrac]

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] | https://t.co/fRviKmkmgn

[RegTrac @regtrac]

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] | https://t.co/fRviKmkmgn

[RegTrac @regtrac]

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] | https://t.co/fRviKmjOqP

[RegTrac @regtrac]

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] | https://t.co/fRviKmkmgn

[RegTrac @regtrac]

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] | https://t.co/fRviKmkmgn

[RegTrac @regtrac]

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] | https://t.co/fRviKmjOqP

[RegTrac @regtrac]

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] | https://t.co/fRviKmjOqP

[RegTrac @regtrac]

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] | https://t.co/fRviKmkmgn

[RegTrac @regtrac]

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] | https://t.co/fRviKmkmgn

[RegTrac @regtrac]

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] | https://t.co/fRviKmkmgn

[RegTrac @regtrac]

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] | https://t.co/fRviKmjOqP