Practice B · Registrations & Certifications
ISO 13485 Certification (Medical Devices QMS)
ISO 13485 certifies a quality management system tailored to medical device design, manufacturing and regulatory requirements, and is often a precondition for CE marking or export approval. We prepare documentation matched to your device class.
At a glance
Why it matters
What ISO 13485 Certification (Medical Devices QMS) gets you
- Often required for medical device export and CE marking
- Tailored to device-specific regulatory requirements
- Certification via an accredited body
Before you start
Documents you'll need
- Business registration proof
- Device classification and manufacturing details
- Existing quality procedures, if any
Process
How we handle it
Consultation
A free call with a filing expert to confirm scope, eligibility and the documents you'll need.
Documentation
We send a checklist and verify every document before anything is submitted — no rejected filings from typos.
Filing
Your application is drafted and lodged with the relevant authority under your assigned expert's name.
Tracking
Live status updates as the filing moves through the registry — visible to you, not just to us.
Delivery & compliance
Certificates or documents delivered digitally, with any recurring deadlines scheduled automatically.
Questions
Frequently asked
How long does ISO 13485 Certification (Medical Devices QMS) take?
15-20 working days.
What documents are required?
You'll need Business registration proof, Device classification and manufacturing details, Existing quality procedures, if any.
How much does it cost?
We quote a fixed fee upfront after a free consultation, since the exact cost depends on your state, entity type, and specific requirement. Government fees, where applicable, are always billed separately at cost.
Do I need to visit an office?
No — the entire process is handled remotely. Documents are collected digitally, and signatures use Aadhaar e-sign or a Digital Signature Certificate where required.
Related
Other services in Registrations & Certifications
Ready to get started with ISO 13485 Certification (Medical Devices QMS)?
Book a free consultation — a filing expert will confirm eligibility and next steps within one business day.