Complaint handling, adverse event reporting & supplier quality
Struggling with complaint backlogs or supplier quality findings? GxP consulting and embedded contractors for medical device and diagnostics quality, built to the QMSR and FDA’s current inspection program.
The challenges this solves
Our complaint records won’t meet the QMSR
Complaint-handling records now carry explicit content and investigation requirements under §820.35.
Reportability calls are hard to defend
MDR, MedWatch and EU vigilance decisions need a documented, consistent decision model and on-time filing.
Supplier and audit records are now inspectable
Supplier audit, quality audit and management review reports lost their prior inspection exemption.
What we deliver
- Complaint intake, triage, investigation and root-cause analysis, with records built to QMSR §820.35
- Reportability decisions and authoring of FDA MDRs and MedWatch (21 CFR Part 803) and EU vigilance / MIR reports under MDR and IVDR
- Post-market surveillance: PMS plans and reports, signal detection, trending, PSUR/PMSR and field safety corrective action support
- Supplier quality: onboarding, qualification and requalification, risk assessments, quality agreements, Approved Supplier List, audits and SCAR
- CAPA and nonconformance management with effectiveness verification
- Validation of complaint-handling, eQMS, post-market and supplier systems, with Part 11 assessments and a risk-based CSA approach
- QMSR transition and ISO 13485:2016 gap assessment; SOP and quality-record remediation
- MDSAP and Notified Body readiness, and mock inspections on FDA Compliance Program 7382.850
Systems and tools
- 21 CFR Part 820 (QMSR)
- ISO 13485:2016
- 21 CFR Part 803
- EU MDR / IVDR
- 21 CFR Part 11
- MDSAP
4 steps, clear deliverables
- 01
Scope
Define the problem and its risk: the reportability question, supplier set, complaint backlog or QMSR gap.
You receive: A scoped path and deliverable list
- 02
Deploy
Place the right senior consultant or team, project-based or embedded under your procedures.
You receive: Named consultants on your work
- 03
Execute
Run the investigations, filings, qualifications and records to current regulation and your SOPs.
You receive: Inspection-ready records and filings
- 04
Sustain
Trending, periodic review and inspection readiness keep the function in a documented state of control.
You receive: Ongoing trending and review
Want to know what this would take for your systems? Start with a short scoping call.
Who we do this for
- Medical devices
- Diagnostics (IVD)
- Biotech
- Pharma & biopharma
Related services
Questions we hear most
Can we hire this as a project or as an embedded contractor?
Either. SQA Solution is both a GxP consulting firm and a life-sciences staffing firm, so you can take scoped project consulting, an embedded contractor working under your QMS, or interim leadership for a complaint-handling, supplier-quality or post-market function.
Are you working to the QMSR or the old QSR?
The QMSR, effective February 2, 2026, together with ISO 13485:2016, FDA Part 803, EU MDR/IVDR and FDA Compliance Program 7382.850, which replaced QSIT.
Do you guarantee regulatory outcomes?
No. We commit to 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.
What does an engagement usually start with?
A pressure point: a reportability decision, a supplier audit, a complaint backlog or QMSR readiness. We put the right consultant on it and come back with a scoped path.
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.