An expert audit of your QMS against ISO 13485
Benchmarked against ISO 13485:2016, delivered within five business days.
A personalised pre-audit of your quality management system against ISO 13485:2016. We review your actual procedures and flag the gaps, weak clauses and nonconformities before your notified body or the FDA does.
Priced at $5,000. Your gap report and 30-minute debrief land within five business days.
Thanks, your request is in. We will email you the mutual NDA the same day and get started.
Clause by clause gap report
A review of your QMS against ISO 13485:2016, clause by clause, so you can see exactly where you stand.
Standards compliance check
We flag any missing or outdated standard references before they turn into findings.
30 minute expert debrief
A live session with one of our quality experts to prioritise the findings and plan your next move.