Implementation, certification and transition to ISO 13485:2016.
How we help
Risk-based ISO 13485 implementation aligned with your design, manufacturing and post-market reality.
Category
Quality Engineering
ISO 13485 Consulting
Implementation, certification and transition to ISO 13485:2016.
Representative work
Clinical engineering workstation
Cleanroom assembly line
Diagnostic instrumentation
Combination product packaging
Device classes & artefacts we support.
The problem
Your registration in international markets requires ISO 13485 — and your auditor will not give you an easy ride.
Our solution
We help with implementation of risk-based ISO 13485 to fit into your design, production, and post-production situation.
Process
How we run this engagement.
Gap analysis vs ISO 13485:2016
Process map & procedure design
Implementation & training
Internal audit + management review
Stage 1 + Stage 2 audit support
Ready to start?
Tell us about your program — we typically respond within one business day.
Book a free 30-min consult