ISO 13485:2016
Specifies requirements for a QMS where an organization demonstrates its ability to provide medical devices and related services that meet customer and regulatory requirements.
ISO 13485:2016 Pricing
Pick the tier that fits your business. All plans include dedicated consultant support and 3-year certificate validity.
Starter
Ideal for startups and small businesses applying for their first certification.
- Dedicated consultant
- Documentation support
- One round of internal audit
- Certification audit support
- Certificate valid for 3 years
Professional
For growing businesses that want full hand-holding and faster turnaround.
- Everything in Starter
- Priority slot for certification audit
- Two rounds of internal audit
- Awareness training session
- Annual surveillance support
Enterprise
Tailored for multi-location enterprises and groups requiring multiple standards.
- Everything in Professional
- Multi-site and multi-standard scope
- Quarterly compliance check-ins
- On-site visits as needed
- CXO level reporting
Why ISO 13485:2016 matters for your business
- Compliance with global medical device regulations
- Easier path to CE, FDA and other approvals
- Stronger risk management for medical products
- Improved product quality and traceability
- Higher trust from hospitals and distributors
- Ready for periodic regulatory audits
Who should apply?
Medical device manufacturers, suppliers, service providers and sterilisation units.
Apply for ISO 13485:2016How we certify you
Application
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Documentation
We help prepare all required documents and management system manuals.
Audit
Internal and certification audits are conducted by qualified auditors.
Certification
Receive your ISO certificate valid for 3 years with annual surveillance.
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