Trust · Quality & Regulatory

Quality & regulatory assurance

How CTARS designs, manufactures and delivers patient-specific surgical devices under a quality-managed, surgeon-reviewed process — from certification to case-by-case sign-off.

ISO 13485 CE marked Pan-India & international
Governance

Quality is designed in, not inspected in

CTARS is India's first and only dedicated 3D design-and-print unit for virtual surgical planning (VSP) and 3D splint fabrication for orthognathic surgery, and one of the few companies worldwide specialising in TMJ total joint replacement. Every patient-specific device — implant, guide, splint or model — is designed by a team of maxillofacial, plastic, oncologic, orthopaedic, neuro and dental surgeons working alongside engineers and designers under one roof, and every design is reviewed and confirmed by the treating surgeon before production begins. [This page summarises CTARS's published quality and regulatory position. Certificate scope, numbers, notified body and expiry are not yet published and are marked below for confirmation before publishing.]

What we stand for

Four pillars of our quality approach

Surgeon-led design review

Every case is designed and reviewed by our in-house surgical team before it reaches you, and you confirm the plan, quote and lead time before anything is produced.

Certified quality management

CTARS operates under an ISO 13485 quality management system and CE-marked processes. [Certificate number, scope statement and notified body — to confirm]

Biocompatible, traceable materials

Implants are produced in titanium and PEEK; splints in PolyJet photopolymer — materials selected for surgical biocompatibility, with case files traceable from scan to delivery.

Controlled manufacturing environment

Design, printing and finishing take place across CTARS's Pan-India and international facilities under consistent process controls. [Facility-level certification and audit cadence — to confirm]

Certifications

Certifications & compliance, by topic

CTARS BROCHURE View PDF
ISO 13485 - DESIGN AND MANUFACTURE CERTIFICATE View PDF
ISO 9001 - RESELLER DISTRIBUTOR FOR STOCK TJR AND STOCK PLATES View PDF
MSDS - TITANIUM ALUMINIUM VANADIUM ALLOY POWDER View PDF
TEST CERTIFICATE MEDICAL GRADE PEEK View PDF
Our process

How CTARS assures quality on every case

1

Case intake & review

Imaging (CT/CBCT/MRI/intraoral scan) is checked for completeness before design begins.

2

Surgeon-reviewed design

Our surgical and engineering team prepares the design or virtual plan and shares it for your review.

3

Confirmed before production

You confirm the plan, quote and lead time — and can request changes — before anything is manufactured.

4

Controlled delivery

The finished device is produced under quality-managed conditions and delivered with its case record. [Conformity documentation issued with delivery — to confirm]

Questions & answers

Regulatory & compliance FAQ

Is CTARS ISO certified?

Yes. CTARS holds ISO 13485 quality management certification. [Certificate number and scope — to confirm]

Are CTARS devices CE marked?

CTARS products are CE marked. [Device classification and declaration of conformity — to confirm]

Who reviews the design before it's made?

The treating surgeon reviews and confirms every design, quote and lead time before production begins, and can request changes first.

What happens to my patient's imaging data?

Imaging is used solely to design your case. [Data retention and protection policy — to confirm]

Are the devices sterilisable?

[Sterilisation method and responsibility — to confirm with the CTARS clinical team.]

Which regions does CTARS operate and certify in?

CTARS operates Pan-India (HQ Chennai) and through CTARS Africa, and is expanding to Vietnam, Malaysia and Dubai. [Region-specific regulatory registrations — to confirm]