When a complaint comes in, a supplier needs requalification, or a reportability clock starts ticking, you need experienced quality professionals who can make defensible decisions and produce inspection-ready records — delivered as a scoped consulting project or an embedded contractor on your team.
Why now
The QMSR is in effect — and it raised the bar on quality records
On February 2, 2026, FDA’s Quality System Regulation became the Quality Management System Regulation (QMSR), amending 21 CFR Part 820 to incorporate ISO 13485:2016 by reference. Complaint-handling records now carry explicit content and investigation requirements, and management review, quality audit, and supplier audit reports have lost their prior inspection exemption — they are all inspectable now.
Current as of 2026. Manufacturers aligned only to the legacy Part 820 have real gaps to close in complaint handling, supplier quality, and recordkeeping. Our consultants close them — and build to the QMSR and FDA’s current inspection program (Compliance Program 7382.850, which replaced QSIT on February 2, 2026), not the superseded QSR playbook.
What we deliver
Senior quality capability across the post-market and supplier lifecycle
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Complaint Handling & Investigation
Intake, triage, investigation, and root-cause analysis, with assessment of regulatory compliance, reportability, and patient-safety impact — and complaint records built to QMSR §820.35.
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Reportability & Adverse Event Reporting
Defensible reportability decisions using event-investigation and decision models, then authoring and on-time transmission of FDA MDRs and MedWatch (21 CFR Part 803) and EU vigilance / MIR reports under MDR & IVDR.
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Post-Market Surveillance
PMS planning and reporting, signal detection, complaint and field-data trending, PSUR/PMSR generation, and field safety corrective action support aligned to EU MDR/IVDR and FDA.
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Supplier Quality Management
Supplier onboarding, qualification and requalification, risk assessments, quality agreements, Approved Supplier List maintenance, supplier audits, and SCAR — with records that hold up under FDA inspection.
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CAPA & Quality System Improvement
CAPA and nonconformance management with effectiveness verification, plus cross-functional QMS improvement across training, internal audits, validation, design control, and post-market surveillance.
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CSV & 21 CFR Part 11 Compliance
Validation of complaint-handling, eQMS, post-market, and supplier systems, with Part 11 assessments and a risk-based Computer Software Assurance approach — still fully in force under the QMSR.
Also included
The supporting work that makes it inspection-ready
- QMSR transition & ISO 13485:2016 gap assessment
- SOP and quality-record remediation
- MDSAP and Notified Body inspection readiness
- Mock inspections on FDA Compliance Program 7382.850
- Regulatory and customer communications drafting
- Cross-functional alignment across complaint, service & quality
- Quality System process-improvement leadership
- Recall and field safety corrective action support
Deliverable-level commitments. We provide defined, scoped deliverables and defensible, inspection-ready evidence. We don’t promise regulatory outcomes — we make your quality position as strong and current as it can be.
How we engage
Consulting project, embedded contractor, or interim leadership
SQA Solution is both a GxP consulting firm and a life-sciences staffing firm — so you can take the same capability the way that fits your situation.
Project consulting
Scoped, fixed-deliverable work: a PMS plan, a supplier qualification program, a complaint-backlog remediation, or a QMSR gap assessment.
Embedded contractor
Quality and regulatory professionals working inside your team, under your QMS and procedures, for as long as you need the capacity.
Interim leadership
Fractional or interim coverage for a complaint-handling, supplier-quality, or post-market function during a transition or surge.
How an engagement works
From pressure point to a controlled, inspection-ready state
STEP 01
Scope
Define the problem and its risk — the reportability question, supplier set, complaint backlog, or QMSR gap.
STEP 02
Deploy
Place the right senior consultant or team — project-based or embedded under your procedures.
STEP 03
Execute
Run the investigations, filings, qualifications, and records to current regulation and your SOPs.
STEP 04
Sustain
Trending, periodic review, and inspection readiness keep the function in a documented state of control.
Why SQA Solution
Current regulation, senior people, two ways to engage
Current with the QMSR
Aligned to the QMSR (effective February 2, 2026), ISO 13485:2016, FDA Part 803, and EU MDR/IVDR — not the retired QSR or last decade’s playbook.
Consulting and staffing under one roof
Take the same capability as a scoped project or an embedded contractor — without re-sourcing through a second vendor.
Named senior consultants
Experienced quality and regulatory practitioners who can defend the work to an inspector — not an anonymous capacity pool.
Life-sciences depth
Two decades placing and deploying life-sciences quality talent for device, diagnostics, and biopharma leaders, including Roche and Genentech.
Tell us where the pressure is
A reportability decision, a supplier audit, a complaint backlog, or QMSR readiness — we’ll put the right consultant on it and come back with a scoped path.
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