Medical Device & Diagnostics Quality
Research that feeds into medical device or in vitro diagnostic development operates under an additional regulatory layer beyond general lab compliance. This sub-cluster covers ISO 13485 (the quality management system standard specific to medical devices), FDA design controls, the EU's In Vitro Diagnostic Regulation (IVDR), pharmacovigilance (the monitoring and reporting of adverse events once a product reaches use), and the regulatory affairs profession that manages submissions and compliance across these frameworks — including the Regulatory Affairs Certification (RAC) credential.
Guides
EU Authorised Representative for Medical Devices: The MDR Article 11 Mandate, Tasks, and Liability
What MDR Article 11 requires from a non-EU manufacturer’s EU authorised representative: mandate contents, minimum tasks, technical documentation access, joint liability, and vigilance duties.
UDI Labeling and GUDID Submission: The Practical Workflow
The GUDID submission mechanics behind UDI labeling: DUNS-based account setup, the Web Interface vs. HL7 SPL submission routes, the required data attributes, and the most common reasons a submission gets rejected.
Class IIa Medical Devices Under EU MDR: Conformity Assessment, Notified Body Scope, and PSUR Requirements
The EU MDR obligations specific to Class IIa devices: which conformity assessment route applies (Annex IX vs Annex XI Part A), how much technical documentation gets reviewed, clinical evaluation depth under Article 61(10), and PSUR frequency versus Class I and Class IIb.
Clinical Evaluation Report (CER) Under EU MDR: Structure, Evidence Sufficiency, and the Equivalence Route
What a clinical evaluation report (CER) must contain under MDR Article 61 and Annex XIV Part A, the MEDDEV 2.7/1 Rev 4 structure notified bodies still expect, how the equivalence route tightened under MDR compared to MDD, and how PMCF findings feed back into the CER.
Complaint Handling for Medical Devices: Intake, Reportability, and the Complaint File
A walkthrough of medical device complaint handling: what counts as a complaint, controlled intake, the MDR/EU MDR vigilance reportability decision, 820.198/ISO 13485 8.2.2 investigation requirements, complaint file record content, and the link into CAPA and trending.
Notified Body Designation and Audits Under MDR/IVDR
How notified bodies get designated under EU MDR/IVDR, what their published scope commits them to, the application and quality-system audit sequence, unannounced audits, and the capacity constraint that drives realistic timelines.
FDA Q-Submission Program: Pre-Subs and Other Device Meetings
A practical guide to FDA’s Q-Submission program for medical devices: choosing between a Pre-Submission, a Study Risk Determination request, and an Informational Meeting, writing questions FDA can actually answer, the feedback timeline, and how much of that feedback is binding later.
Predicate Device and Substantial Equivalence: Choosing and Justifying a 510(k) Predicate
How to choose a defensible 510(k) predicate: the intended-use-then-technological-characteristics test, the substantial equivalence decision tree, multiple and split predicates, and why a candidate predicate’s recall history matters.
Design History File (DHF): What Belongs In It, and What Doesn’t
A DHF documents how a device was designed, not how it was built or that a specific unit was built correctly. Here is what actually belongs in one, what commonly gets miscategorized, and how it differs from the DMR and DHR.
Design Controls for the Medical Device Industry
Design controls turn a device concept into a verified, validated design ready for production: planning, testable inputs, genuine outputs and how they trace together, review, verification, validation, transfer, and change control — and how the design history file records it, under the current QMSR / ISO 13485 Clause 7.3 citation.
PMCF Plan Under EU MDR Annex XIV Part B: Structure, Study Triggers, and the PSUR Link
How to build a PMCF plan that satisfies MDR Annex XIV Part B: the seven MDCG 2020-7 sections, when literature review alone is defensible, when a dedicated PMCF study is required (the Article 61(4) trigger), and how PMCF findings feed the CER and the PSUR.
IVDR (EU 2017/746): Classification, Notified Body Requirements, and Transition Deadlines
How EU IVDR (Regulation 2017/746) classifies in vitro diagnostics into Class A-D, why most devices now need Notified Body conformity assessment instead of self-certification, and which Article 110 transition deadlines are still open.
Post-Market Surveillance (PMS) Plan: Structure, Data Sources, and How It Differs From PMCF
What an EU MDR post-market surveillance plan must contain under Article 83 and Annex III, the real data sources that feed it, how it differs from FDA’s Section 522 surveillance orders, and exactly where PMS ends and PMCF begins.
FDA Premarket Cybersecurity for Medical Devices: Section 524B, SBOM, and Threat Modeling
What FDA’s premarket reviewers actually check under Section 524B: the cyber device test, the SBOM, the secure product development framework, threat modeling, and how cybersecurity risk analysis diverges from ISO 14971.
IEC 62366-1: The Usability Engineering Process, Step by Step
IEC 62366-1 defines a fixed five-step usability engineering sequence — use specification, safety-related UI characteristics, known use problems, hazard-related use scenarios, and summative evaluation — and, since Amendment 1:2020, hands the acceptability call for any unresolved use-related risk to the device’s ISO 14971 risk management file rather than deciding it internally.
ISO 13485 Certification: Scope, Stages and Audit Preparation
What the ISO 13485 certification process actually requires: how the scope statement on your certificate is fixed, the IAF MD 9 audit-day table your quote should reconcile to, what stage 1 and stage 2 each test, which nonconformities block the certification decision and for how long, and the surveillance and recertification obligations that follow.
EUDAMED: Module-by-Module Status, What Is Mandatory Now, and the SRN Registration Sequence
EUDAMED rolls out module by module. Which of the six are mandatory, which are proposed, and the actor/SRN, UDI-DI and certificate registration sequence behind them, each with its own date.
Field Safety Corrective Action (FSCA): FSCA vs Recall vs Field Safety Notice, and the EU/US Cross-Walk
An FSCA is not a recall and a recall is not a field safety notice. The decision criteria, the conditional EU MDR Article 87 notification clocks, the Article 89(8) FSN requirements, and how all of it maps onto FDA 21 CFR 806 and 21 CFR 7.
IEC 62304: Software Safety Classes, Lifecycle Deliverables, and SOUP Requirements
A clause-level map of IEC 62304 Edition 1.1: what Amendment 1:2015 changed about software safety classification, which deliverables each of classes A, B and C actually demands, the four SOUP obligations that catch teams using open-source components, and why FDA’s Basic/Enhanced Documentation Levels are not the same test as clause 4.3.
ISO 14971: The Risk Management File, Benefit-Risk Determination, and the ISO/TR 24971 Cross-Walk
ISO 14971:2019 requires a traceable risk management file, not a risk table. What clause 4.5 must contain, how clause 7.4 and clause 8 benefit-risk determinations differ, the ALARP-to-AFAP trap for the EU MDR, and the ISO/TR 24971:2020 cross-walk for the clauses 14971 leaves thin.
21 CFR Part 820: Subpart-by-Subpart Map and QMSR Transition Status
Part 820 is now the QMSR. A subpart-by-subpart map of where every legacy Quality System Regulation requirement went, what DMR, DHR and DHF are called now, and what a manufacturer actually changes.
Laboratory Developed Tests: Current FDA Regulatory Status
FDA oversight of laboratory developed tests (LDTs) changed twice in under two years: a May 2024 final rule extending device regulation to LDTs was vacated by a federal court in March 2025, and FDA reverted the regulatory text in September 2025. This guide states the current position, date-stamped, with the FDA source.
Software as a Medical Device (SaMD): Definition, Classification, and Regulatory Pathways
Before any FDA pathway question comes a prior one: is the software a device at all? The 21st Century Cures Act section 3060 carve-outs — clinical decision support under section 520(o)(1)(E), medical device data systems, and the general wellness compliance policy — decide that, and FDA’s current CDS guidance is dated January 2026. Then the IMDRF risk categories, the US classification and pathway, EU MDR Rule 11, and AI/ML oversight.
ISO 13485: Medical Device Quality Management Systems Explained
ISO 13485:2016 is the standalone international standard for medical-device quality management systems. A clause-by-clause walkthrough of what each requirement means and what an auditor asks you to produce, the ISO 9001 deltas that trip organisations arriving from general quality management, and exactly which clauses the FDA QMSR supplements.
FDA Guidance on Biocompatibility: ISO 10993 Explained
How FDA’s biocompatibility guidance applies ISO 10993-1’s risk-based framework to 510(k), PMA, De Novo, IDE, and HDE submissions — including how to choose the test battery by contact type and duration, and the 2023 intact-skin update.
