Benefits of ISO 13485:2016 Certification
Mandatory for medical device export
CDSCO registration support
EU MDR compliance
US FDA readiness
Reduces recall risk
Global market access
Our ISO 13485:2016 Certification Process
1
Gap Analysis
Free initial review of your systems against ISO 13485:2016 requirements.
2
Documentation
Our experts prepare quality manuals, SOPs, and all required records.
3
Training & Review
Internal audit training, management review, and mock pre-audit checks.
4
Certification Audit
IAF Certification Body conducts Stage 1 & Stage 2 audits with our full support.
5
Certificate Issued
Your ISO 13485:2016 certificate is issued — valid for 3 Years.
6
Surveillance Audits
Annual surveillance audits to maintain your certification.
Documents Required for ISO 13485:2016
Company registration
Device master record
Risk management file
Design & development records
Post-market surveillance plan
Clinical evaluation report
Our consultants help prepare most documents from scratch. Just share basic company information.
5,000+
Certified in India
28
States served
98%
Pass rate
What's Included in ₹13,999?
Gap Analysis
Free initial assessment against ISO 13485:2016 requirements
Included
Documentation
Complete manuals, SOPs, and all required records
Included
Expert Consultant
Dedicated ISO consultant for your project
Included
Internal Audit Training
Mock audit preparation and training
Included
CB Liaison
Coordination with IAF-accredited Certification Body
Included
Certificate
Official ISO 13485:2016 certificate
Included
1-Year Support
Support for first surveillance audit
Included
Hidden Charges
No surprise fees ever
₹0 Extra
FAQs — ISO 13485:2016
The cost of ISO 13485:2016 certification through ISO Registration India is ₹13,999. This is fully all-inclusive — gap analysis, documentation, internal audit support, CB liaison, and pre-audit training. No hidden charges.
With ISO Registration India's expert guidance, ISO 13485:2016 certification typically takes 30-40 Days. Our pre-prepared documentation templates and expert consultants significantly reduce time compared to self-application.
ISO 13485:2016 certification is valuable or mandatory for: Medical Device Manufacturers, Healthcare Equipment. It provides a strong competitive advantage in government tenders, export markets, and enterprise procurement.
Yes. Certificates issued by our IAF-accredited partner Certification Body are globally recognised — by government bodies, international buyers, and regulators worldwide.
Key documents: Company registration, Device master record, Risk management file, Design & development records, Post-market surveillance plan, Clinical evaluation report. Our consultants help prepare most of these from scratch.
Yes! We offer a fully online service. Gap analysis, documentation, training, and pre-audit support are all delivered remotely. The physical audit is conducted at your premises.
We provide full corrective action support to address non-conformances at no extra charge. Our 98% first-time pass rate reflects our thorough pre-audit preparation.
ISO 13485:2016 certificates are valid for 3 Years. Annual surveillance audits maintain certification. After 3 years a recertification audit is required. We support all stages.