ISO & Quality Systems
ISO 13485 (Medical Devices)
ISO 13485 Medical Devices QMS
Quality management system certification for medical device makers.
What you get
- QMS documentation to ISO 13485
- Design & risk-file support
- Certification audit coordination
Frequently asked
Who needs ISO 13485 Medical Devices QMS?
Medical device manufacturers and suppliers.
How long does it take?
Typically 8-16 weeks, depending on documentation and any testing or audit involved.
What does it cost?
You receive a fixed consultancy charge upfront with any government or lab fees itemised separately — nothing begins until you approve.
Can you handle it end-to-end?
Yes — from documentation and filing to follow-up with the authority and the final certificate in hand.