Your audit date
is set. Are you
actually ready?
We audit medical device manufacturers for a living. That means we know exactly what an MDSAP, EU MDR, or FDA auditor will look for — and exactly where your gaps are hiding.
FDA QMSR went live February 2, 2026. If your internal audit program still references old QSR sections, your last audit is non-compliant — and FDA can now inspect those records.
What keeps Quality Managers
awake at 2am.
An audit is approaching and you're not sure you'll pass
Your team has been doing things a certain way for years. But regulatory requirements have changed. You don't know what the auditor will find — and that uncertainty is costly.
Your supplier management has gaps you haven't documented
Supplier oversight is the number one source of findings in MDSAP and EU MDR audits. An approved supplier list without audit records and risk justification is a nonconformity waiting to happen.
FDA QMSR changed your compliance framework on February 2
Old QSR section numbers no longer exist. Your internal audit program, SOPs, and training records all need to be updated — and FDA can now review every one of them during inspection.
You're trying to align multiple regulatory schemes at once
ISO 13485, EU MDR, MDSAP, UKCA — each has different requirements. Maintaining four separate compliance tracks is expensive and inefficient. There is a smarter approach.
SA Quality Solutions brings together a team of Lead Auditors and Quality Management specialists with over a decade of active Notified Body experience — auditing medical device manufacturers across every major regulatory scheme worldwide.
Every recommendation we make is grounded in what auditors actually find during certification audits — not theoretical best practices from people who have never conducted one.
Our Background →QMSR Transition Readiness
Assessment
Know exactly where your QMS stands — in 5 business days.
FDA QMSR went live on February 2, 2026. If your internal audit program still references old QSR section numbers, every audit conducted since that date is measuring against withdrawn requirements. FDA can now inspect your audit records. This assessment tells you exactly what to fix — before your next inspection.
- Complete review of your current internal audit program against QMSR requirements
- Gap report with prioritized findings mapped to specific QMSR provisions
- Updated internal audit checklist aligned to ISO 13485 + QMSR supplemental provisions
- Document change list — every SOP and record that needs updating, with specific language
- 60-minute debrief call with findings review and remediation roadmap
- Written summary report suitable for Management Review input
QMSR Readiness Assessment
One flat fee. No surprises. Delivered remotely.
Delivered in 5 business days from kickoff
- Gap report with prioritized findings
- Updated audit checklist (yours to keep)
- Document change list
- 60-min debrief call included
- Written Management Review summary
Auditor-informed consulting
across every major scheme.
Build an audit program that holds up under scrutiny.
We design and run internal audit programs aligned to ISO 13485, MDSAP, EU MDR, and FDA QMSR — using the same methodology NB auditors apply.
- Audit planning and program design
- Harmonized multi-scheme checklists
- NCR documentation and CAPA follow-up
- Auditor qualification support
Find your gaps before an auditor does.
A structured assessment of your current QMS against regulatory requirements — with a prioritized remediation plan, not just a list of findings.
- Full QMS regulatory gap mapping
- Prioritized finding report
- Documentation review
- Implementation roadmap
Outsourcing a process doesn't outsource accountability.
Supplier management gaps are the most common finding in MDSAP and EU MDR audits. We build supplier oversight systems that actually hold up.
- Risk-based supplier classification
- Supplier qualification and audits
- Quality agreement development
- Ongoing performance monitoring
One audit. Five jurisdictions. Done right.
End-to-end MDSAP implementation covering FDA, Health Canada, ANVISA, MHLW/PMDA, and TGA — from QMS documentation through certification audit support.
- Five-jurisdiction gap assessment
- QMS documentation alignment
- Mock audits pre-certification
- Certification audit support
EU MDR technical files that pass Notified Body review.
Technical file review, GSPR assessment, CER strategy, and conformity assessment preparation — from someone who has reviewed hundreds of technical dossiers as a lead NB auditor.
- MDR Annex II & III compliance review
- GSPR assessment and gap mapping
- CER review and strategy
- Certification readiness preparation
Train your team the way auditors are trained.
Hands-on regulatory training built from real audit experience. Not slides from a manual — practical instruction on what auditors actually look for and how to prepare your team.
- ISO 13485, MDSAP, EU MDR, QMSR
- Internal auditor training
- Audit preparation workshops
- Custom case studies from real findings
