Quality Systems

Detailed analysis of MedTech Europe's May 2026 position paper on the proposed MDR/IVDR revision. Covers breakthrough/orphan pathways, cybersecurity, AI integration, IVDR-specific concerns, and what manufacturers need to know about the coming legislative process.

Breaking down the FDA's May 2026 one-day inspection pilot that uses AI (Elsa) to target low-risk facilities. Covers how facilities are selected, what to expect during a screening inspection, how it differs from standard inspections, and what medical device manufacturers must do to stay ready.

A field-by-field evidence matrix mapping MDR Annex II/III technical documentation, ISO 14971 risk management, PMS/PMCF, cybersecurity, data governance, human oversight, and QMS records to EU AI Act high-risk obligations — for manufacturers who must comply with both frameworks simultaneously.

How to build the Unresolved Software Anomalies table for FDA premarket cybersecurity submissions — CVSS scoring, exploitability assessment, clinical impact analysis, compensating controls, SBOM linkage, VEX status, labeling language, release criteria, and common reviewer objections.

Practical due-diligence checklist for evaluating the FDA Third Party Review (3P510k) Program — product-code eligibility verification, Accredited Person selection, conflict-of-interest screening, eSTAR compatibility, FDA final-determination risk, timeline and cost tradeoffs, and when to avoid third-party review.

Step-by-step guide to building a dual PMSR/PSUR reporting architecture that satisfies both EU MDR/IVDR and Great Britain SI 2024/1368 requirements — data-period alignment, GB-specific content, MHRA standardized format, FSCA linkage, trend reporting, record retention, and responsible-owner mapping.

Operational guide to the invalid-result workflow for home-use and self-test IVDs — covering invalid rate targets, lay-user error coding, repeat-test instructions, IFU comprehension, customer support scripts, specimen collection errors, adverse event handling, and postmarket trending.

A practical guide to implementing MDR Article 88 trend reporting — covering denominator selection, expected frequency calculation, statistical significance testing, severity escalation, complaint coding, CAPA linkage, PSUR/PMSR integration, and the MDCG 2025 draft Q&A requirements.

Practical guide to change control for NGS bioinformatics pipelines in IVD devices — covering variant caller updates, reference database changes, threshold modifications, wet-lab/software interface validation, IEC 62304 documentation, revalidation triggers, and postmarket records.

How to draft ISO 13485 / QMSR-compliant supplier quality agreements for critical outsourced vendors — cloud hosting providers, AI model/data vendors, penetration testing firms, ASCA/non-ASCA test labs, and sterilization vendors — with clause-by-clause guidance, vulnerability notification clauses, audit rights, CAPA cooperation, change notification, and evidence records.

Operational guide to converting an RUO-labeled assay or reagent into a cleared or approved IVD — covering marketing claims cleanup, distributor scripts, customer notices, historical data triage, validation bridge strategy, complaint transition, sales training, and evidence firewall construction.

2026 is the most consequential year for medical device UDI compliance globally. Mandatory deadlines hit in the EU (May 28), Switzerland (July 1), Australia (July 1), and China. This guide covers every active UDI system, class-by-class deadlines, data requirements, and what happens if you miss them.

Practical guide to the top 12 FDA cybersecurity deficiencies causing premarket submission holds in 2026 — SBOM gaps, threat modeling failures, risk assessment mistakes, and fixes aligned with the February 2026 final guidance and Section 524B.

Protocol-level guide to cleaning validation for reusable surgical instruments — covering artificial soil selection, protein/hemoglobin/TOC endpoints, worst-case device families, manual vs automated cleaning, ANSI/AAMI ST98 acceptance criteria, sample size justification, and report structure.

Downloadable GSPR checklist template for EU MDR Annex I compliance — covering all 23 requirements across three chapters, with columns for applicability assessment, evidence files, harmonised standards mapping, gap analysis, owner assignment, and remediation tracking. Practical alternative to gated competitor templates.

Manufacturer-facing guide to reprocessing validation for reusable medical devices under ISO 17664-1, ISO 17664-2, FDA guidance, and EU MDR — covering cleaning, disinfection, sterilization validation, worst-case device families, IFU content, and premarket submission evidence.

Protocol-level analytical validation guide for IVD manufacturers — covering test plan tables, acceptance criteria, sample selection, statistical methods per CLSI standards, and FDA/EU IVDR expectations for analytical performance evidence.

Practical PMCF Plan template aligned with MDCG 2020-7 and EU MDR Annex XIV Part B — covering objectives derivation from CER gaps, method selection (registries, surveys, studies, literature), endpoint definition, sample size logic, schedule, triggers, PMCF evaluation report structure, and PMS integration.

Comprehensive regulatory strategy guide for pre-filled syringes and auto-injectors as drug-device combination products — covering FDA OCP/RFD jurisdiction, ISO 11608 design verification, human factors validation, EU MDR Article 117, QMSR quality system implications, stability testing, and lifecycle change management.

Step-by-step guide to writing reprocessing instructions for reusable medical device IFUs — covering point-of-use treatment, cleaning, disinfection, sterilization, drying, storage, reuse life claims, warnings, usability validation, and audit readiness per FDA guidance, ISO 17664, and ISO 20417.