Registrations & Certifications · ISO Standards
ISO 13485 Certification (Medical Devices QMS)
Get ISO 13485 certified — the quality management standard specific to medical device manufacturing.
- Timeline15-20 working days
- Documents3 items
- Process100% online
About 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.
ISO certificates are issued by independent certification bodies after an audit. We prepare your documentation, coordinate the audit and remind you of surveillance audits.
What you get
- Often required for medical device export and CE marking
- Tailored to device-specific regulatory requirements
- Certification via an accredited body
Documents required
- Business registration proof
- Device classification and manufacturing details
- Existing quality procedures, if any
Exact requirements vary by state and entity. We confirm the final list on the first call.
How we handle it
- 1
Tell us the goal
Pick a service, or describe what you're trying to do and we'll suggest the right registration or structure.
- 2
Get a written quote
A LegalReet expert calls back, confirms scope and eligibility, and sends a fixed fee in writing.
- 3
Upload documents
Share the checklist documents over WhatsApp or email. We check every page before anything is filed.
- 4
We file and follow up
Your application is prepared, filed and chased with the department by the same expert who quoted you.
- 5
Certificate delivered
Approvals arrive digitally, along with the recurring due dates that now apply to your business.
Fees
Our professional fee for ISO 13485 Certification (Medical Devices QMS) starts at Rs 10,999. Government fees, stamp duty and GST depend on your state and case and are itemised in the written quote we send before work begins.
Frequently asked questions
How long does ISO 13485 Certification (Medical Devices QMS) take?
Typically 15-20 working days, counted from the date we receive complete documents. Department processing times can stretch this, and we keep you updated throughout.
What documents do I need for ISO 13485 Certification (Medical Devices QMS)?
You will usually need: Business registration proof; Device classification and manufacturing details; Existing quality procedures, if any. We send a tailored checklist after the first call.
How much will it cost?
Our professional fee for ISO 13485 Certification (Medical Devices QMS) starts at Rs 10,999. Government fees, stamp duty and GST depend on your state and case and are itemised in the written quote we send before work begins.
Do I need to visit your office?
No. Documents are shared over WhatsApp or email, signatures are done with Aadhaar e-sign or a DSC where required, and approvals are delivered digitally. You are welcome to visit our Agra office if you prefer.
Who will handle my file?
A LegalReet expert from the relevant desk is assigned when you confirm, and stays your point of contact until delivery. Work is reviewed by a qualified professional before filing.
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Speak to a LegalReet expert at no cost. We'll recommend the right structure, give you a realistic timeline and confirm the full fee in writing before you pay anything.