Your audit date
is set. Are you
actually ready?
Independent QMS audit-readiness and remediation support, informed by lead-auditor and medical device quality system experience. We understand how QMS evidence is evaluated during FDA inspections, ISO 13485/MDSAP audits, customer audits, and Notified Body reviews — and we help you organize yours before the audit date arrives.
FDA QMSR became effective on February 2, 2026. If your internal audit program, SOPs, checklists, or training records still reference legacy QSR structure, they may not fully reflect the current QMSR framework. A focused readiness assessment helps identify needed updates, prioritize remediation, and organize objective evidence before your next FDA inspection, ISO 13485/MDSAP audit, customer audit, or Notified Body review.
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 controls are a frequent source of audit findings, especially where supplier qualification, monitoring, quality agreements, and outsourced-process controls are not well documented. 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 provides independent audit-readiness and remediation support informed by lead-auditor and quality-system experience across ISO 13485, MDSAP, EU MDR, and FDA QMSR — spanning manufacturers of every size and device class.
Every recommendation we make is grounded in how QMS evidence is actually evaluated during external audits and inspections — not theoretical best practices.
Our Background →QMSR / ISO 13485
Readiness Assessment
Know where your QMS stands before your next inspection or external audit.
A focused readiness assessment for medical device manufacturers and suppliers preparing for FDA inspection, ISO 13485/MDSAP audit, customer audit, supplier audit, or Notified Body review. Internal audits conducted against legacy QSR references may not fully align with the current QMSR framework — and those records may be reviewed during FDA inspection.
- Internal audit program and record review
- Selected CAPA, complaint, and supplier-control record review
- Management review and quality metrics review
- Gap report with prioritized findings
- Updated audit checklist and document change list
- 30/60/90-day remediation roadmap
- Written summary suitable for Management Review input
QMSR / ISO 13485 Readiness Assessment
Fixed fee after scope review. Remote or onsite delivery.
Typical delivery in 2–3 weeks from kickoff, depending on scope
- Gap report with prioritized findings
- Updated audit checklist (yours to keep)
- Document change list
- 30/60/90-day remediation roadmap
- 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 external auditors apply.
- Audit planning and program design
- Harmonized multi-scheme checklists
- NCR documentation and CAPA follow-up
- Auditor qualification support
Identify and prioritize your QMS gaps before your next external audit.
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 control gaps are among the most frequently cited areas 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 documentation prepared for Notified Body review.
Technical file review, GSPR assessment, CER strategy, and conformity assessment preparation — grounded in extensive experience reviewing technical dossiers under EU MDR conformity assessment.
- 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
- De-identified case examples and common audit finding patterns
Your next audit is coming.
Let's make sure you're ready.
Request a QMS Readiness Discussion →
Audit-tested expertise
across every major
regulatory scheme.
Every service we deliver is informed by lead-auditor and medical device QMS experience — 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 external 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
Identify and prioritize QMS gaps before your next external audit.
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 against QMSR and ISO 13485 and deliver a complete, prioritized remediation package.
- Internal audit program and record review
- Gap report with priorities
- Updated checklist and document change list
- 30/60/90-day roadmap and 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
A frequent source of audit findings.
Supplier oversight gaps are among the most frequently cited areas in MDSAP and EU MDR audits, especially where qualification, monitoring, quality agreements, and outsourced-process controls are not well documented. 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 documentation readiness support for Notified Body review.
Our experience includes extensive technical documentation review under EU MDR conformity assessment. We know 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 priority gaps across all five MDSAP jurisdictions and provide a risk-based remediation plan before the audit — 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 a frequent source of audit findings.
Builds a complete, audit-ready supplier management program from scratch. Closes one of the most frequently cited sources 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 are not ready to fund a full-time senior hire. Senior 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. A 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?
Request a QMS Readiness Discussion →
Experience from
both sides
of the audit.
SA Quality Solutions is led by Svetlana Abel, a senior medical device quality and regulatory professional with extensive experience in ISO 13485, MDSAP, EU MDR/MDD, FDA QMSR, CAPA, complaints, supplier controls, internal audits, audit readiness, and QMS remediation.
Lead-auditor experience
working for you.
SA Quality Solutions is led by Svetlana Abel, a senior medical device quality and regulatory professional with more than 20 years of experience spanning manufacturer quality organizations, Notified Body technical management, and lead auditing across ISO 13485, MDSAP, EU MDR, MDD, IVDR, and UKCA schemes. Additional qualified QMS, audit, regulatory, and technical SMEs may support projects based on scope and availability.
That background includes 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.
The experience spans 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 how QMS evidence is actually evaluated during external audits and inspections — not theoretical best practice.
Ready to work with someone
who knows both sides?
Request a QMS Readiness Discussion →
Audit tools built from
real audit experience.
Templates, checklists, and tools developed from 15+ years of hands-on audit and quality-system experience. 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.