Resource Library
Glossary
Medical Device Glossary
Quality and regulatory terms tied to their governing rule or standard.
All Topics
Open the GlossaryWalkthroughs
Failure to Follow Written Procedures in a 2026 Warning Letter
A May 2026 warning letter cites five ISO 13485 clauses and no section of the CFR. Three of the findings say the firm did not follow its own written procedures.
Audits & Enforcement · Quality System
Read the WalkthroughArticles
What the QMSR Adds to ISO 13485:2016
Part 820 requires a quality system that complies with ISO 13485:2016 and adds a short set of FDA-specific requirements.
Quality System
Read the ArticlePurchasing Control Citations Rose 19% in FY2025
What the FDA’s inspection records show about supplier oversight and what they cannot yet show about the QMSR.
Suppliers, Change & CAPA
Read the ArticleCAPA Root Cause and Effectiveness Checks
Defining the effectiveness check before the investigation starts shapes the root cause that follows.
Suppliers, Change & CAPA · Audits & Enforcement
Read the ArticleDesign Change Routes: 510(k), PMA Supplement, or Documentation
The triggers for a new 510(k) and a PMA supplement, and the documented decision for a change that meets neither.
Suppliers, Change & CAPA
Read the ArticleGuides
The Executive Playbook for Health Authority Audit Readiness & Remediation
A structured guide to preparing for FDA and Notified Body inspections before the inspection is announced, and to responding when it doesn’t go as planned.
Audits & Enforcement
Request This GuideStructuring End-to-End Design Control Files for High-Complexity Medical Devices
A practical framework for building design history files and risk management files that hold together under both internal review and external audit.
Design Controls & Risk
Request This GuideSheets
Software Documentation Level Decision Sheet
Which of the FDA’s ten Table 1 documentation elements actually change between Basic and Enhanced. Seven of ten stay identical. Only the SDS, development and configuration practices, and testing differ.
Regulatory Pathways · Design Controls & Risk
View the SheetReading a 2026 Warning Letter
A warning letter cites the rule in force when the inspection closed, not when the letter arrives. The longest gap measured between the two dates was 329 days, long enough to span the QMSR transition.
Audits & Enforcement · Quality System
View the SheetWarning Letter Composition Sheet
CAPA leads every device warning letter category tracked: 73% of FY2026 letters that allege a quality-system violation cite it, up from 54% in FY2024, against six other categories scored the same way.
Audits & Enforcement
View the SheetThird-Party Model Supplier File
The FDA’s generative AI discussion paper names four device risks and sets no supplier requirements. The six-section supplier file a bought-in foundation model already owes under ISO 13485 Clause 7.4.
Suppliers, Change & CAPA · Design Controls & Risk
View the SheetData
Warning Letter Data
Device warning letters by category and fiscal year, tracked directly from the FDA’s own public postings.
Audits & Enforcement · Quality System
See the DataForm 483 Inspection Data
Form 483 citations by category, and warning letters per 100 Form 483s.
Audits & Enforcement
See the DataClass I Recall Data
137 Class I recall events since July 2025, every one firm-initiated.
Audits & Enforcement
See the DataDiagnostics
Form 483 & Inspection Readiness Diagnostic
A directional read on inspection readiness, built from the frameworks used in FDA reviews.
Audits & Enforcement
Run the DiagnosticEU MDR Technical Dossier Completeness Diagnostic
A directional read on how complete a technical dossier is against EU MDR expectations.
Regulatory Pathways
Run the DiagnosticQMSR Readiness Diagnostic
A directional read on readiness for the QMSR transition.
Quality System
Run the DiagnosticDesign Controls & V&V Diagnostic
A directional read on design history file and verification and validation readiness.
Design Controls & Risk
Run the DiagnosticChange Control & Lifecycle Governance Diagnostic
A directional read on how defensible change-control decisions are.
Suppliers, Change & CAPA
Run the DiagnosticNo resources match both filters. Clear one to see more.
Procurement teams: request the Capabilities Statement & Partner Profile.