InvestigationRoot cause established with evidence§8.5.2 b
CAPAAction planned, owned and dated§8.5.2 d
EffectivenessAction verified to have worked§8.5.2 f
ClosureRecord closed and audit-ready§4.2.5
The quality event lifecycle tracked by MedQA Launch: intake, triage, investigation, CAPA, effectiveness check and closure, each mapped to the ISO 13485 clause that governs it.
Built on the frameworks that govern medical device quality
The quality problems that slow medical device companies down
Compliance gaps surface too late
Find deviations from ISO 13485, the FDA QMSR and EU MDR before they become audit findings or 483 observations.
Audit prep is reactive and manual
Replace spreadsheet checklists with an MDSAP readiness assessor that scores your posture from your actual company profile.
Acquisitions bring hidden quality debt
When you acquire a company you inherit its design history. Map the gaps before they become a regulatory liability.
Four tools, built around how auditors read a quality system
Quality Event Lifecycle Manager
Every complaint, nonconformance and CAPA, traced from intake to closure.
Reporting clocks start at awareness
2 daysEU serious public health threat MDR Art. 87(4)
5 work daysFDA, remedial action needed 21 CFR 803.53
10 daysEU death or unanticipated serious deterioration MDR Art. 87(5)
15 daysEU serious incident MDR Art. 87(3)
30 calendar daysFDA death or serious injury 21 CFR 803.50
Connects to the systems you already run and keeps one record per quality event. Triage, reportability decisions, investigation, CAPA and effectiveness checks are documented, timestamped and attributable, with regulatory reporting clocks visible from day one.
Live status of any quality event at any stage
Full triage and handling audit trail
Reporting deadlines tracked for FDA and EU vigilance
Export-ready records for auditors and submissions
Standards: ISO 13485 §8.2.2, §8.3, §8.5.2; 21 CFR Part 803; EU MDR Art. 87
MDSAP Audit Readiness Assessor
Know your posture before the auditor walks in.
TGAAustralia
ANVISABrazil
Health CanadaCanada
MHLW / PMDAJapan
FDAUnited States
One MDSAP audit: ISO 13485:2016 plus each jurisdiction's requirements
Answer structured questions about your company and product portfolio. The assessor scores readiness against ISO 13485:2016 and the country-specific requirements of all five MDSAP regulators, then ranks the remediation work.
Profile-driven scoring across all five MDSAP jurisdictions
Gaps ranked by risk and regulatory weight
Remediation plans with named owners
Standards: MDSAP AU P0002; ISO 13485:2016
DHF Gap Assessment Tool
See what you inherited in an acquisition, and what needs fixing.
Example gap map of an acquired DHF
Design plan§7.3.2Present
Inputs§7.3.3Present
Outputs§7.3.4Partial
Reviews§7.3.5Present
Verification§7.3.6Partial
Validation§7.3.7Missing
Transfer§7.3.8Missing
Changes§7.3.9Partial
Risk fileISO 14971Partial
Present Partial Missing
Maps an acquired company's design history file against your own QMS, element by element across design controls and the risk management file, so regulatory surprises surface before integration, not during an inspection.
Acquiree DHF compared against acquirer QMS requirements
Risk-weighted gap register with remediation priorities
Integration roadmap aligned to post-merger timelines
Standards: ISO 13485 §7.3; ISO 14971:2019; 21 CFR Part 820 (QMSR)
QMS Compliance Posture Assessment
Benchmark your QMS against every framework you sell under.
FDA QMSR
§820.35 record content
§820.45 labeling and packaging
Part 803 reporting
Part 806 corrections and removals
EU MDR / IVDR
Art. 10 manufacturer obligations
Art. 15 PRRC
Art. 83-86 PMS and PSUR
Art. 27 UDI
MDSAP
Country-specific requirements of five regulators
Audit model per AU P0002
ISO 13485:20164 QMS5 Management6 Resources7 Realization8 Measurement and improvement
A structured assessment of your QMS against ISO 13485:2016, the FDA Quality Management System Regulation, EU MDR/IVDR and other applicable frameworks, producing a clause-by-clause posture report you can act on.
Multi-framework benchmarking in a single assessment
Clause-by-clause scoring with evidence mapping
Posture tracked across assessment cycles
QMSR and MDR/IVDR transition planning
Standards: ISO 13485:2016; 21 CFR Part 820 (QMSR); EU MDR/IVDR
Built by practitioners, not theorists
MedQA Launch tools are designed by professionals with decades of hands-on experience in medical device quality, regulatory affairs and compliance across FDA, EU MDR and MDSAP jurisdictions. Every workflow reflects how auditors think, not just what the standards say.
Questions quality teams ask
What is MedQA Launch?
MedQA Launch is a set of four software tools for medical device quality and regulatory teams: a quality event and CAPA lifecycle manager, an MDSAP audit readiness assessor, a post-acquisition DHF gap assessment tool, and a QMS compliance posture assessment that benchmarks against ISO 13485, the FDA QMSR and EU MDR/IVDR.
What changed when the FDA QMSR took effect?
The Quality Management System Regulation took effect on February 2, 2026. It replaced the old Quality System Regulation by incorporating ISO 13485:2016 into 21 CFR Part 820 by reference, while keeping FDA-specific requirements such as record content (§820.35) and labeling and packaging controls (§820.45). The terms DHF, DMR and DHR are no longer used in the regulation; the equivalent ISO 13485 records are the design and development file and the medical device file.
What is MDSAP and which regulators take part?
The Medical Device Single Audit Program lets one audit of a manufacturer satisfy five regulators: the TGA (Australia), ANVISA (Brazil), Health Canada, MHLW and PMDA (Japan), and the US FDA. The audit covers ISO 13485:2016 plus each jurisdiction’s specific requirements. Health Canada requires an MDSAP certificate for Class II to IV device licences.
What should a post-acquisition DHF gap assessment cover?
At minimum, every design control element in ISO 13485 §7.3 (planning, inputs, outputs, reviews, verification, validation, transfer and design changes) and the ISO 14971 risk management file. Each element of the acquired file is compared with what the acquirer’s QMS requires, and each gap is ranked by patient risk and regulatory exposure.
How quickly must serious incidents be reported?
Under FDA 21 CFR Part 803, manufacturers report device-related deaths and serious injuries within 30 calendar days, or within 5 work days when remedial action is needed to prevent unreasonable risk or FDA requests it. Under EU MDR Article 87, serious incidents are reported within 15 days, deaths or unanticipated serious deterioration in health within 10 days, and serious public health threats within 2 days of awareness.
Who are the tools built for?
Directors of Quality, regulatory affairs leads, QA/RA consultants and M&A integration teams at manufacturers of Class I, II and III devices, software as a medical device (SaMD), in vitro diagnostics and contract manufacturers.
How do I get access?
Complete the request access form on this page with your company profile and the tools you are interested in. The team follows up within 2 business days with an overview tailored to your device classes and markets.
Tell us about your quality challenges
Share a few details. We'll follow up within 2 business days with a tailored overview.