What is ISO 13485?
ISO 13485 is the international standard for medical devices quality management. Certification shows customers, regulators and tender authorities that your organisation follows a documented, audited system.
ISO 13485 is often a prerequisite for CDSCO medical device licences, CE marking and exports.
Who Needs ISO 13485?
- Medical device manufacturers
- Suppliers and distributors of medical devices
Advantages of ISO 13485
Many government and corporate tenders require ISO certification.
Shows commitment to international standards.
Documented systems reduce errors and waste.
Recognised by buyers worldwide.
Documents Required for ISO 13485
Organisation
- Business registration proof
- PAN and GST certificate
- Scope of activities
- Organisation chart and process details
- Existing policies and records (if any)
We share an exact checklist for your case after the consultation. Scanned copies or clear phone photos are fine.
How We Get It Done
- 1Gap analysis
We assess your current system against the standard.
- 2Documentation
Manual, procedures and records are prepared.
- 3Internal audit
Readiness is checked and gaps closed.
- 4Certification audit
The certification body conducts the audit.
- 5Certificate
ISO 13485 certificate issued, valid for 3 years.
Frequently Asked Questions
3 years, with surveillance audits every year.
We work with certification bodies accredited by recognised accreditation boards. Always verify accreditation before choosing a body.