RegXtrakt

One platform for life sciences compliance — Regulatory at the core, Quality, Safety & Labelling connected. First filing to lifelong maintenance.

[RegXtrakt @RegXtrakt]

🚀 Ready to bring your medical device to India?

The right regulatory strategy can mean the difference between a smooth market entry and costly delays.

Follow us for practical guidance, regulatory updates, and insights that help you move forward with confidence.

[RegXtrakt @RegXtrakt]

🚨 Vigilance
📋 PSURs
📡 Signal detection

RegXtrakt helps manage device PMS systematically.

#Materiovigilance #MedicalDevices #CDSCO

[RegXtrakt @RegXtrakt]

Recurrence is a quiet quality failure. Close a CAPA today, only to see the same issue return tomorrow.

RegXtrakt helps prevent recurrence with:
🔄 Linked CAPA & root causes
🤖 Recurrence risk prediction
📈 Risk-based prioritisation

Close the loop. Keep it closed.

[RegXtrakt @RegXtrakt]

Every auditor asks for the ISO 14971 risk file.

The question is: can you trace every hazard to the evidence?

Risk management protects patients. Traceability proves it.

#ISO14971 #MedTech #Quality

[RegXtrakt @RegXtrakt]

ISO 13485 ≠ Fifth Schedule compliance.

For India’s Class A & B device manufacturers, MD-5 audits are against the Fifth Schedule of MDR 2017.

RegXtrakt maps every clause, shows live compliance gaps, and helps your team stay audit-
#MDR2017 #ISO13485 #MedicalDevices #Quality

[RegXtrakt @RegXtrakt]

India’s MedTech infrastructure is scaling fast. 🇮🇳

₹3,420 Cr PLI + new Medical Device Parks = more manufacturing.
But more production also means more audits, licences, and compliance.
Scale your QMS as fast as your factory.

#MedTech #MakeInIndia #PLI #QMS #CDSCO

[RegXtrakt @RegXtrakt]

India’s MedTech story in 3 numbers:

📈 +88% export growth (FY19–FY25)

🏭 10% → 30% domestic production share

🎯 US$20B export potential by FY30

The opportunity is global. Compliance will decide who wins.
#MedTech #MedicalDevices #MakeInIndia

[RegXtrakt @RegXtrakt]

A licence isn’t the finish line. It’s a living obligation.

Renewals. Post-approval changes. Periodic compliance. Miss one deadline, and the cost can be far greater than a reminder.

Stay audit-ready. Stay ahead.
#CDSCO #MedicalDevices #RegulatoryAffairs #MedTech

[RegXtrakt @RegXtrakt]

“What class is your device?” is where every regulatory pathway begins.

With CDSCO tightening classification requirements, getting it right has never been more important.

Know your class before you file.

#CDSCO #MedTech #RegulatoryAffairs #Compliance

[RegXtrakt @RegXtrakt]

One suite. Five modules. Every medical device obligation in one place.

Meet RegXtrakt for Medical Devices.

Built for CDSCO & MDR 2017—not adapted from pharma.

Regulatory. Quality. Safety. Labelling. Security.

One platform. Complete compliance.

#RegXtrakt #MedTech #RegTech

[RegXtrakt @RegXtrakt]

India's MedTech market didn't grow from ~400 to 4,000+ manufacturers despite regulation—it grew because of it.

With strict CDSCO risk pathways (Class A–D) now standard, regulatory compliance is no longer a hurdle. It’s core infrastructure.

#MedTech #CDSCO #Healthcare

[RegXtrakt @RegXtrakt]

🇮🇳 India’s MedTech market is set to reach US$50.1B by 2030.

Growth is the opportunity. Compliance is the gate.

Follow our 20-day India MedTech series.

#IndianMedTech #MedicalDevices #CDSCO #RegulatoryAffairs

[AKT Health Analytics (AKTヘルス) @AKTHealth]

Introducing @RegXtrakt , #AI-powered #regulatory ops for #RegulatoryAffairs, Quality, Safety & Labelling, unified

https://t.co/3DXTMHeyFz

#RegTech #RegulatoryOps #HealthcareInnovation

[RegXtrakt @RegXtrakt]

A safety signal isn't just a PV problem. It's a labelling change, a variation, sometimes a market action.

RegXtrakt Safety lives on the same core as Regulatory — a signal lands in the same record your renewals are built from.

#Pharmacovigilance #DrugSafety #RegTech

[RegXtrakt @RegXtrakt]

10 years strong.
AKT Health is honored to partner with the Medical Device Regulatory and Quality Summit 2026 as Silver Partner.

Catch us in New Delhi this August.

#AKTHealth #MedDeviceCompliance

[RegXtrakt @RegXtrakt]

Regulatory complexity is inevitable. Confusion doesn’t have to be.

#Compliance #RegulatoryAffairs

[RegXtrakt @RegXtrakt]

A safety signal isn't just a PV problem. It's a labelling change, a variation, sometimes a market action.

RegXtrakt Safety lives on the same core as Regulatory — a signal lands in the same record your renewals are built from.

#Pharmacovigilance #DrugSafety #RegTech

[RegXtrakt @RegXtrakt]

Stay ahead of regulations, not behind deadlines. 📋

#RegXtrakt #RegTech

[RegXtrakt @RegXtrakt]

AKT Health is participating as a Silver Partner at the 10th Annual Medical Device Regulatory & Quality Summit 2026!
📅 18–19 August 2026
📍 Pride Plaza Hotel, Aerocity, New Delhi.

See you in New Delhi! 🇮🇳
#MedicalDevice #RegulatoryAffairs #DigitalHealth #AKTHealth