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audit program still references old QSR section numbers, every audit conducted since that date is measuring against withdrawn requirements.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
Your next audit is coming.
Let's make sure you're ready.
Schedule a Free 30-Min Call →
Audit-tested expertise
across every major
regulatory scheme.
Every service we deliver is informed by what we've seen as auditors — the gaps that get manufacturers cited, the documentation that satisfies regulators, and the programs that hold up under scrutiny.
What we do — and
the problems we solve.
Programs that hold up under NB scrutiny.
We design internal audit programs the way Notified Body auditors are trained to look at them — risk-based, evidence-driven, and built to survive inspection.
- ISO 13485, MDSAP, EU MDR, FDA QMSR
- Harmonized multi-scheme checklists
- Auditor qualification support
- NCR and CAPA documentation
Find the gaps before the auditor does.
A structured regulatory gap assessment of your current QMS — not a generic checklist, but a review tied to your specific documentation, processes, and device portfolio.
- Full QMS regulatory gap mapping
- Risk-prioritized finding report
- Remediation plan and implementation support
- Management Review documentation
FDA QMSR went live February 2, 2026.
Your internal audit program, SOPs, and training records all need to reflect the new regulatory structure. We assess your current status and deliver a complete remediation package in 5 days.
- Internal audit program review
- Gap report with priorities
- Updated checklist and document list
- Written Management Review summary
One audit. Five jurisdictions.
End-to-end MDSAP implementation designed to meet FDA, Health Canada, ANVISA, MHLW/PMDA, and TGA simultaneously — reducing your audit burden while maximizing coverage.
- Five-jurisdiction gap assessment
- QMS documentation alignment
- Mock audits pre-certification
- Certification audit support
The most common source of audit findings.
Supplier oversight gaps appear in virtually every MDSAP and EU MDR audit we've ever conducted. We build supplier control systems that are audit-ready before the auditor walks in.
- Risk-based supplier classification
- Qualification and ongoing audits
- Quality agreement development
- Performance monitoring programs
EU MDR technical files built to pass NB review.
We've reviewed hundreds of technical dossiers from the other side of the table. We know exactly what Notified Bodies look for — and what gets flagged at every stage.
- MDR Annex II & III review
- GSPR assessment
- CER strategy and review
- Certification readiness preparation
Audit-ready before the auditor walks in.
For manufacturers preparing for MDSAP certification, surveillance, or recertification audits. We identify every gap across all five jurisdictions before the audit begins — using the same methodology MDSAP auditors apply.
- Five-jurisdiction QMS gap report — FDA, Health Canada, ANVISA, MHLW/PMDA, TGA
- Audit-ready document checklist with prioritized remediation actions
- Mock audit interview prep for management and process owners
Close the most common source of audit findings.
Builds a complete, audit-ready supplier management program from scratch. Closes the number-one source of nonconformities in MDSAP and EU MDR audits — and gives you a system that holds up under inspection.
- Risk-based supplier classification matrix — built from your specific supplier list
- Supplier qualification SOP, quality agreement template, and audit checklist
- Annual supplier audit plan and performance monitoring framework
Executive-level QA leadership without the full-time hire.
For startups and growing manufacturers that need a Director of Quality but aren't ready to fund a $185K+ full-time role. Senior, Notified Body-trained QA leadership on retainer — ready to engage Notified Bodies, FDA, and your internal team.
- Strategic QMS oversight, Management Review chair, and quality KPI ownership
- Direct interface with Notified Bodies, FDA, and external auditors on your behalf
- Mentorship of internal QA team and CAPA escalation authority
EU MDR Article 15 compliance, fulfilled.
Named Person Responsible for Regulatory Compliance for legal manufacturers placing CE-marked devices on the EU market. SGS NB1639-trained PRRC with active EU MDR experience — not a name on a form, but an actively engaged regulatory function.
- Named PRRC designation per EU MDR Article 15 — available to your Notified Body
- Technical documentation, GSPR, and Declaration of Conformity oversight
- Post-Market Surveillance, PSUR, and vigilance reporting authority
- Direct interface with Notified Body and Competent Authorities
Senior RA leadership without the full-time hire.
Ongoing regulatory affairs support across FDA, EU MDR, MDSAP, and UKCA — for manufacturers without a dedicated full-time RA function or those needing senior-level support alongside an existing team.
- Regulatory strategy, submission planning, and pathway determination
- 510(k), De Novo, IDE, EU MDR technical documentation, and CE submission support
- Change assessment and regulatory impact analysis on design or process changes
- Direct communication with FDA, Notified Bodies, and Competent Authorities
Not sure which service
you need first?
Free 30-Min Consultation →
A team that has been
on the other side
of every audit.
Our team brings together experienced Lead Auditors and Quality Management specialists who spent over a decade working inside Notified Bodies — conducting, managing, and making decisions on medical device certification audits worldwide.
Notified Body experience
working for you.
Every member of our team has hands-on Notified Body audit experience — not consulting experience, not training experience, but active certification audit experience. We have conducted and managed hundreds of audits across the full spectrum of medical device regulatory frameworks, device classifications, and manufacturer profiles.
Our team includes Lead Auditors and Technical Managers qualified across ISO 13485, MDSAP, EU MDR, MDD, IVDR, and UKCA schemes, with direct experience evaluating Quality Management Systems, technical documentation, supplier controls, post-market surveillance programs, and design and development processes for manufacturers of all sizes and device types.
We have audited Class I, Class II, and Class III devices — from consumables and diagnostics to implantables, active devices, software as a medical device, and sterile products. That breadth means we understand not just what the regulations say, but how they are applied differently depending on your device, your market, and your risk profile.
Every gap assessment, audit program, and remediation plan we deliver is grounded in what auditors actually find — not theoretical recommendations from people who have never conducted a certification audit themselves.
Ready to work with a team
that knows both sides?
Schedule a Free Call →
Audit tools built from
real NB experience.
Templates, checklists, and tools developed from 15+ years of conducting and managing certification audits. Free to download and use.
Professional-grade tools,
no cost.
Harmonized Multi-Scheme Internal Audit Kit
Complete audit toolkit covering ISO 13485, FDA QMSR, EU MDR, MDSAP (all 5 jurisdictions), and ISO 19011. Includes auditor qualification form, annual audit plan, harmonized checklist, and audit report template.
Sterilization Validation Package
Documentation and service overview for sterilization validation — EO, radiation, moist heat, sterile barrier. Covers ISO 11135, ISO 11137, ISO 17665, ISO 11607, and regulatory alignment across FDA, EU MDR, MDSAP, and ISO 13485.
Risk Management Documentation Package
Complete harmonized risk management system: ISO 14971:2019, FDA QMSR, EU MDR, MDSAP (5 jurisdictions), UK MDR. SOP, plan, report, dFMEA, pFMEA — 14 audit-ready documents.
GCP / ISO 14155 Clinical Investigation Audit Checklist
100+ criteria covering GCP, ISO 14155:2020, regulatory submissions (FDA IDE & EU MDR), monitoring, safety reporting (AE/SAE/SADE/USADE), and QMS integration.
Need something beyond
a template?
Let's Talk →
Let's talk about
your situation.
A free 30-minute call is the fastest way to figure out what you actually need — and whether we're the right fit to help.
We respond within
one business day.
Location
West Palm Beach, Florida
Availability
Remote engagements globally
Book a free 30-minute discovery call. No pitch. Just an honest conversation about your compliance situation and whether we can help.