EU MDR / IVDR

Guide to the GLP-1 drug delivery device ecosystem, including auto-injector pens, oral delivery, combination product pathways, FDA, EU MDR, and market outlook.

Analysis of EU MDR and IVDR Notified Body capacity using 2026 survey data, review timelines, certification bottlenecks, IVDR Class C risk, and manufacturer actions.

Guide to CSRD sustainability reporting for medical device companies, covering scope, ESRS standards, double materiality, Omnibus simplification, timelines, and practical compliance steps.

How to select, evaluate, and change Notified Bodies under EU MDR and IVDR — capacity constraints, selection criteria, transfer process, 2026 implementing regulation, and timeline planning.

Apply Good Clinical Practice to medical device trials under ISO 14155:2026 and ICH E6(R3), with sponsor duties, consent, safety reporting, and audit readiness.

Use a section-by-section EU MDR CER template covering clinical evaluation plans, literature search, appraisal tables, equivalence, benefit-risk, PMCF links, and evidence traceability.

Practical guide to medical device CVD programs, including PSIRT setup, vulnerability intake, CVSS scoring, SBOM linkage, FDA Section 524B, EU expectations, and customer communication.

Downloadable EU MDR GSPR checklist template for Annex I evidence mapping, applicability, standards, gap analysis, ownership, and remediation tracking.

Learn the 10 most common EUDAMED registration mistakes before the May 28, 2026 mandate, including data, UDI, actor, certificate, and workflow errors, plus fixes.

Regulatory guide for home-use and self-test IVDs, covering FDA OTC and CLIA pathways, EU IVDR self-testing, human factors, labeling, specimen errors, and PMS.

Protocol-level guide to IVD analytical validation, covering LoD, LoQ, precision, interference, cross-reactivity, stability, CLSI methods, and FDA/IVDR evidence.

Assess medical devices with nanomaterials, including EU MDR Rule 19, FDA guidance, ISO 10993-22, exposure frameworks, nanotoxicology, sterilization, labeling, and regulatory strategy.

Regulatory strategy for NGS IVD devices, covering FDA pathways, EU IVDR classification, companion diagnostics, bioinformatics validation, and postmarket controls.

Use this EU MDR PMCF plan template to define objectives, methods, endpoints, timelines, reports, PMS integration, and MDCG 2020-7 traceability.

Regulatory strategy for pre-filled syringes and auto-injectors, covering FDA OCP/RFD, ISO 11608, human factors, EU MDR Article 117, QMSR, stability, and lifecycle changes.

Regulatory strategy guide for surgical robots, covering FDA pathways, EU MDR expectations, autonomy levels, software controls, human factors, and clinical evidence.

Practical guide to RUO, IUO, and IVD labeling boundaries, covering intended use, FDA guidance, diagnostic-use triggers, marketing risk, and classification decisions.

Guide to the 2026 EU MDR Well-Established Technology delegated acts, expanded device lists, clinical investigation exemptions, conformity assessment changes, and manufacturer steps.

Guide to medical device benefit-risk analysis, covering ISO 14971 residual risk, EU MDR AFAP expectations, FDA benefit-risk factors for PMA, De Novo, and 510(k), examples, and documentation.

Demonstrate clinical equivalence under EU MDR Article 61 and Annex XIV, including MDCG 2020-5 criteria, data access, gap analysis, and CE marking examples.