01
Quality management system
i-Fix Certification & licensing
Scope you can
check yourself.
Quality-system, conformity and manufacturing-licence documents, presented with the scope, validity and licence number printed on the source document — not a marketing summary of it.
2Certificates on file
100%In-house quality sign-off
02 Quality documentation
Certification,
licensing and scope.
Quality-system, conformity and manufacturing-licence documents presented with their visible scope and validity—not as decorative badges.
Medical-device documentation
Traceable quality information for professional review.
Request the latest verified PDF where a preview is shown. Dates, scope and product coverage remain defined by each source document.
Request current documents →02
Conformity document
CE — Dental Implants & Prosthesis
Archive preview. Request the latest verified document from Kamal Medtech.03
Manufacturing licence · Form MD-9
Dental Implant with Abutment & Prosthesis
Licence MFG/MD/2019/000057 · Open full PDF ↗ 50,000 sq ft Medical-device manufacturing facility
8 Implant series in the current portfolio
4 In-house stages: machining, clean-room, inspection, packaging
100% Of implants manufactured, not outsourced
03 Verification
Compliance you can
check from wherever you are.
Certificates and the manufacturing licence are prepared to the same standard whether the request comes from a domestic clinic or an overseas regulatory reviewer.
Domestic quality audits
Certificates align with routine ISO 13485 quality-system audits at the Faridabad facility.
Export documentation
Conformity and licence documents are prepared in the format international distributors need for their own market registration.
Direct verification
Any certificate here can be verified against the source document on request — no third-party reseller in between.
Certified & documentedISO 13485 · CE marked
04 Quality is a process, not a plaque
The same clean-room
the certificate describes.
ISO 13485 and the manufacturing licence aren't wall decorations — they describe the actual clean-room processing, inspection and packaging steps every implant passes through before it's released.
05 Frequently asked
What people ask
before onboarding.
What is Kamal Medtech's manufacturing licence?
Form MD-9, Licence MFG/MD/2019/000057, covering Dental Implant with Abutment & Prosthesis — the full licence PDF is linked above.
How current are the certificates shown here?
Each certificate card states its type and note directly from the source document. Request the latest verified PDF for the current revision and full scope.
Can distributors get a compliance pack for onboarding?
Yes — bulk documentation, quality-system and conformity records are available on request through the Partnership or Contact page.
Is i-Fix manufactured to a documented quality system?
Yes. Machining, clean-room processing, inspection and packaging all happen inside Kamal Medtech's Delhi NCR facility under one quality system.
Onboarding as a distributor and need a compliance pack?
Bulk documentation, quality-system and conformity records are available on request for regional onboarding.