European Union

How to conduct management reviews for medical device companies per ISO 13485 Clause 5.6 and FDA QMSR — required inputs, outputs, frequency, documentation, and common audit findings.

Prepare an EU MDR Article 86 PSUR with class-based frequency, MDCG 2022-21 structure, EUDAMED submission, PMS data, and benefit-risk analysis.

Compare QA and QC in medical device manufacturing, including process vs product focus, team roles, tools, organizational structure, and QMSR alignment.

Build medical device quality culture with leadership practices, ISO 13485 management responsibility, behavioral indicators, audits, and FDA QMSR expectations.

Conduct medical device complaint, NCR, and audit finding investigations with root cause methods, CAPA, and ISO 13485, FDA 21 CFR 820, and EU MDR alignment.

Build medical device quality KPIs for CAPA effectiveness, first pass yield, complaints, design controls, cost of quality, and ISO 13485 and QMSR alignment.

Guide to medical device root cause analysis, covering 5 Whys, fishbone diagrams, fault tree analysis, Pareto charts, CAPA links, and FDA 483 risks.

Medical device SBOM guide covering FDA cyber device requirements, NTIA minimum elements, SPDX and CycloneDX formats, VEX integration, tooling, and postmarket management.

Learn how to prepare, validate, translate, and publish EU MDR SSCPs under Article 32, including MDCG 2019-9 Rev.1, lay summaries, NB review, and EUDAMED.

Build a medical device traceability matrix linking user needs, design inputs, risk controls, and V&V for FDA, ISO 13485, IEC 62304, and EU MDR.

Guide to the European Commission MDR and IVDR simplification proposal, including software Rule 11, certificate validity, sandboxes, fees, timelines, and manufacturer impact.

Manage EU MDR Field Safety Corrective Actions, including FSCA triggers, 2/10/15-day reports, Field Safety Notices, EUDAMED, and FDA recall differences.

Guide to complaint handling for medical devices under FDA QMSR, ISO 13485, and EU MDR, covering intake, reportability, CAPA links, records, and audits.

How to classify hand sanitizer, mouthwash, personal lubricants, and data recorders as medical devices or non-devices across FDA, EU MDR, Brazil ANVISA, and Mexico COFEPRIS.

Guide to FDA and EU regulation of drug-device combination products, covering OCP jurisdiction, RFDs, 21 CFR Part 4, EU MDR Article 117, CGMPs, and post-market duties.

Role-by-role playbook for the May 28, 2026 EUDAMED deadline, covering actor registration, UDI/device data, certificates, surveillance duties, and final readiness steps.

See where CE marking supports device approvals across 25+ markets, including full reliance, abridged review, evidence acceptance, and remaining local steps.

What manufacturers should do after missing the 2024 MDR Notified Body deadlines, including legal status, withdrawal timing, fresh MDR applications, and sell-off rules.

Guide to digital therapeutics regulation in 2026, covering FDA 510(k), De Novo, PMA, EU MDR classification, Germany's DiGA reimbursement route, clinical evidence, and global approvals.

Validate medical device packaging to ISO 11607, including sterile barriers, material qualification, aging studies, distribution simulation, seal testing, and shelf-life claims.