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
Six months. Every engagement
delivered on schedule.
Supplier, internal, and mock audits completed and closed. A full ISO 13485 quality management system built for a startup, structured for MDSAP from day one. EU MDR requirements integrated into an established certified QMS ahead of Notified Body review.
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 →
First half 2026:
delivered results.
Every SA Quality Solutions engagement completed between January and June 2026 was delivered on schedule and on scope. Client identities are withheld under confidentiality obligations; each summary below reflects a completed engagement.
What we delivered,
January through June.
Supplier, internal, and mock audits — completed and closed.
Delivered supplier audits, internal audit programs, and pre-certification mock audits for medical device manufacturers preparing for FDA inspection, ISO 13485 and MDSAP certification audits, and customer audits. Every audit report was issued within days of the closing meeting, with findings written as CAPA-ready observations tied to specific clause requirements rather than generic checklist output.
Why it matters to you: an audit is only useful if the findings survive contact with your external auditor. Ours are written the way external audit findings are written, because that is the standard your evidence will be judged against.
A complete ISO 13485 QMS for a startup — MDSAP-ready from day one.
Built a full ISO 13485:2016 quality management system for an early-stage device company, structured from the first procedure for MDSAP compatibility across all five jurisdictions: FDA, Health Canada, ANVISA, MHLW/PMDA, and TGA. The system was scaled to the client's actual headcount and product risk — a lean, maintainable QMS the team can actually run, not a 200-procedure template that collapses at the first surveillance audit.
Why it matters to you: a startup that builds MDSAP compatibility in from day one avoids restructuring its entire QMS when it enters the US, Canadian, or other MDSAP markets. That restructuring is where most early-stage quality budgets go to die.
EU MDR requirements integrated into an established certified QMS.
Extended an existing ISO 13485 certified quality management system to incorporate EU MDR (2017/745) requirements: post-market surveillance and vigilance procedures aligned to Articles 83 through 92, technical documentation structured per Annexes II and III, and PRRC responsibilities established under Article 15. The client entered Notified Body review with a complete, review-ready documentation set.
Why it matters to you: ISO 13485 certification alone does not satisfy EU MDR. The gap between the two is where Notified Body findings concentrate — and closing it before submission is far cheaper than closing it under a nonconformity deadline.
Every engagement above was delivered by SA Quality Solutions LLC and is founded on more than 500 career audits conducted across Notified Body, MDSAP, and manufacturer settings. That is the experience base behind every gap report, audit program, and remediation plan we produce.
Now scheduling
Q1 and Q2 2027.
If you need to establish a quality management system under any medical device scheme, complete remediation of audit findings, or conduct internal or supplier audits, send a request through the contact form or email info@saqms.com.
We solve the problems
that put your market
access at risk.
Organized around the problems medical device manufacturers actually face — audit exposure, quality system gaps, regulatory submissions, and the leadership vacuum that stalls growth. Every solution is informed by lead-auditor and medical device QMS experience.
Don't need a project — need a quality leader one or two days a week? Fractional Director of Quality, Interim VP, and executive advisory engagements give you senior QA leadership without a full-time hire.
Know the outcome
before the auditor arrives.
An audit date on the calendar is a deadline with financial consequences. A failed FDA inspection, a Notified Body nonconformity, or a stage-two MDSAP finding can suspend shipments, delay CE marking, or trigger warning letters. We assess your readiness against the exact framework the auditor will apply, then close the gaps before they become findings.
Executive Audit Defense
Problem. When FDA or a Notified Body is on site, the outcome turns on how executives and process owners perform in the room. One unprepared management interview or a document produced without context can convert a routine inspection into a finding.
Solution. End-to-end defense for a live inspection or high-stakes audit: preparation before, and hands-on support through every day the auditor is on site.
Deliverables.
- Executive and process-owner interview coaching
- Management Review preparation
- Mock FDA and Notified Body interviews
- Document review and front-room readiness
- Daily on-site support for the duration of the inspection
Outcome. Your leadership faces the auditor prepared and supported, and the inspection stays routine instead of escalating.
FDA QMSR Readiness
Problem. QMSR took effect February 2, 2026. Internal audit programs, SOPs, and training records built on legacy QSR section numbers no longer map to the regulation, and FDA can now inspect management review, internal audit, and supplier audit records that were previously exempt.
Solution. A structured readiness assessment against the current QMSR framework and ISO 13485, including the records now exposed to inspection under the withdrawn 820.180(c) exemption.
Deliverables.
- Gap report with prioritized findings
- Updated internal audit checklist and document change list
- 30/60/90-day remediation roadmap
- Written Management Review summary
Outcome. You enter your next FDA inspection knowing what will be found, with the exposed records defensible and the gaps closed.
Mock FDA Inspection
Problem. Teams that have never been inspected, or whose last inspection predates QMSR and the retirement of QSIT, do not know how their front room, back room, and records will hold up under CP 7382.850.
Solution. A full simulated FDA inspection run to current inspection procedure, including document requests, floor interviews, and management interviews, conducted by someone who understands how evidence is evaluated.
Deliverables.
- Simulated inspection to CP 7382.850
- Observation report in 483-style format
- Front-room and back-room process assessment
- Interview coaching for management and process owners
Outcome. Your team walks into the real inspection rehearsed, calm, and aware of exactly where the risk sits.
ISO 13485, MDSAP & Notified Body Preparation
Certification, surveillance, and recertification readiness for ISO 13485, MDSAP across all five jurisdictions, and EU MDR Notified Body review. We identify priority gaps and provide a risk-based remediation plan before the audit, using the methodology the auditor applies.
- ISO 13485:2016 certification and surveillance readiness
- MDSAP five-jurisdiction gap assessment and mock audit
- Notified Body review preparation for EU MDR
- Prioritized, risk-based remediation plan
Independent audits
that hold up under scrutiny.
Supplier and internal audit gaps are among the most frequently cited areas in MDSAP and EU MDR audits. We conduct independent audits written the way external audit findings are written, so the results survive contact with your certification body, your customer, and FDA.
Supplier Controls, Before They Become Your Next Major Finding
Problem. Poor supplier controls create regulatory risk, quality issues, and potential production delays. An approved supplier list without audit records and risk justification is a nonconformity waiting to happen.
Solution. Independent supplier audits conducted against ISO 13485, FDA QMSR, and applicable regulatory requirements, with findings tied to specific clause requirements.
Deliverables.
- Audit plan
- Audit report with nonconformities
- Supplier risk assessment
- Executive summary and recommended CAPAs
Outcome. Greater supplier confidence, improved compliance, and reduced operational risk.
Internal & Second-Party Audits
Internal audit programs and second-party audits run to the same methodology external auditors apply. Risk-based, evidence-driven, and documented so the records strengthen your position rather than expose it.
- Internal audits against ISO 13485, MDSAP, EU MDR, QMSR
- Second-party audits of partners and contract manufacturers
- Harmonized multi-scheme checklists
- NCR documentation and CAPA follow-up
Corporate Multi-Site Audits
Coordinated audit programs across multiple manufacturing sites, harmonized to one methodology so corporate quality gets comparable results and consistent risk visibility across the network.
- Multi-site audit program design
- Harmonized checklists and reporting across sites
- Comparative findings and risk analysis
- Corporate-level executive rollup
Fix the system,
not just the finding.
A closed CAPA that does not address root cause reopens as a repeat finding. We build and remediate the quality subsystems that regulators scrutinize most, so the fix holds through the next audit cycle instead of resurfacing.
CAPA Remediation
Problem. Ineffective CAPA is one of the most cited quality system failures. Corrective actions that do not reach root cause generate repeat findings and, under QMSR, sit in records FDA can now inspect.
Solution. Independent review and remediation of your CAPA system and open records, with root-cause rigor and traceable closure.
Deliverables.
- CAPA system assessment against ISO 13485 and QMSR
- Open-record review with root-cause evaluation
- Remediation plan and closure verification
- CAPA effectiveness-check framework
Outcome. A CAPA system that closes findings for good and demonstrates a self-correcting QMS under inspection. See our full medical device QMS remediation services.
QMS Development
Problem. Startups and scaling manufacturers need a quality system that satisfies regulators without drowning a small team in procedure, and a template QMS collapses at the first surveillance audit.
Solution. A full ISO 13485 quality management system built to your headcount and product risk, structured for MDSAP compatibility from the first procedure.
Deliverables.
- Complete ISO 13485:2016 QMS documentation
- MDSAP-ready structure across five jurisdictions
- Scaled procedure set matched to your operation
- Implementation and rollout support
Outcome. A lean, certifiable QMS your team can actually run, with no costly restructuring when you enter new markets.
Risk, Supplier Quality, Complaints, Management Review & Metrics
Targeted build and remediation of the individual quality subsystems that carry the most regulatory weight, delivered as standalone engagements or bundled into a broader QMS improvement plan.
- Risk management to ISO 14971:2019
- Supplier quality program and quality agreements
- Complaint handling and vigilance systems
- Management review and quality metrics frameworks
Market access,
engineered correctly.
Every market has its own conformity route, and a submission that misreads the pathway costs months. We plan and prepare regulatory submissions across FDA, EU MDR, UKCA, and MDSAP, and review the technical documentation Notified Bodies scrutinize most.
Technical Documentation That Holds Up Under Notified Body Review
Problem. Under EU MDR, technical documentation gaps are where Notified Body findings concentrate, and a deficient Annex II or III file stalls CE marking at conformity assessment.
Solution. Independent review of your technical documentation against EU MDR requirements, grounded in extensive dossier-review experience under conformity assessment.
Deliverables.
- Annex II and III compliance review
- GSPR assessment and gap mapping
- Clinical evaluation report strategy and review
- Conformity-assessment readiness report
Outcome. A technical file that clears Notified Body review the first time, protecting your CE timeline.
Multi-Scheme Regulatory Strategy
Regulatory pathway planning and submission support across FDA, EU MDR, UKCA, and MDSAP, for manufacturers entering new markets or maintaining conformity across several at once.
- FDA pathway determination and submission support
- EU MDR and UKCA conformity strategy
- MDSAP alignment across five jurisdictions
- Change assessment and regulatory impact analysis
Senior quality leadership,
without the full-time hire.
This is where SA Quality Solutions differs from most consultancies. Beyond project work, we step into the leadership seat: chairing management review, facing your Notified Body and FDA directly, and carrying board-level quality accountability during the moments that decide a company's trajectory.
Executive QA Leadership
Problem. Startups and growing manufacturers need Director- or VP-level quality leadership before they can justify a full-time senior hire, and a leadership gap during a certification push or FDA engagement stalls the whole company.
Solution. Senior quality leadership delivered in the engagement model that fits the situation:
- Fractional Director of Quality — ongoing, part-time senior leadership on retainer
- Interim VP Quality — full-time leadership covering a defined gap or transition
- Executive Advisory — board- and founder-level quality and regulatory counsel
Deliverables.
- Strategic QMS oversight and Management Review chair
- Direct interface with Notified Bodies, FDA, and external auditors
- Quality KPI ownership and CAPA escalation authority
- Mentorship of the internal QA team
Outcome. Executive quality authority engaged the moment you need it, at a fraction of the cost and risk of a permanent hire.
Due Diligence & Acquisition Quality Review
Problem. Acquiring a medical device company means inheriting its quality liabilities: open findings, deficient technical files, and CAPA backlogs that surface after the deal closes and destroy the valuation.
Solution. Independent quality and regulatory due diligence on an acquisition target, surfacing the liabilities before they become yours.
Deliverables.
- QMS and regulatory-status assessment of the target
- Technical documentation and certification review
- Open-finding, CAPA, and compliance-liability register
- Risk-rated executive report for the deal team
Outcome. You enter the transaction knowing the true quality exposure, with leverage to price it or remediate it before close.
Regulatory Strategy Advisory
Senior regulatory counsel for leadership teams making pathway, market-entry, and portfolio decisions, delivered as ongoing advisory rather than document production.
- Market-entry and pathway strategy across jurisdictions
- Portfolio-level regulatory planning
- Change and impact assessment on design or process moves
- Direct counsel to founders and executive teams
Experience across
the device landscape.
Quality and regulatory work spanning Class I, II, and III devices, from implantables and active devices to software and diagnostics. Each carries its own risk profile and regulatory expectation, and the differences are where audits are won or lost.
What the work
looks like in practice.
Anonymized summaries of completed engagements. Client identities and identifying details are withheld under confidentiality obligations. Each reflects the kind of risk closed and compliance secured.
First ISO 13485 certification for an early-stage manufacturer.
Assessed the quality system ahead of first certification, identified gaps across the internal audit program and documentation, redesigned the CAPA system, and delivered a prioritized remediation roadmap. The client entered Stage 2 with the previously exposed areas closed and defensible.
QMSR readiness for a Class II manufacturer.
Reviewed an audit program still written to legacy QSR references, mapped the gaps against the current QMSR framework, and updated the internal audit approach and document set. Focused specifically on the management review and supplier records newly exposed to FDA inspection, reducing the client's inspection risk before their next FDA engagement.
EU MDR requirements built into a certified QMS.
Extended an established ISO 13485 certified system to meet EU MDR, aligning post-market surveillance and vigilance to the regulation, structuring technical documentation for Notified Body review, and establishing PRRC responsibilities. The client entered conformity assessment with a complete, review-ready file.
Not sure which solution
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.
Trusted by medical device manufacturers seeking practical solutions, not generic consulting. We help organizations prepare for FDA inspections, ISO 13485, MDSAP, customer audits, and Notified Body assessments through risk-based, auditor-informed quality system improvements.
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 →
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.