IVD & Diagnostics

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

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

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

Guide to LDT regulation after FDA's 2024 rule was vacated, covering CLIA oversight, enforcement discretion, ACLA litigation, and steps laboratories should take.

Compare IVD registration requirements across MENA, including Saudi SFDA, UAE EDE, Egypt EDA, Turkey TITCK, Israel AMAR, companion diagnostics, performance evidence, and point-of-care rules.

Practical guide to IVDR Annex VIII classification rules for IVD Classes A-D, with device examples, software guidance, IVDD-to-IVDR changes, and the 2025 EU simplification proposal.

Guide to companion diagnostic regulation, including FDA approval pathways, EU IVDR requirements, therapeutic co-development, PMA and De Novo strategy, and market access evidence.

Guide to point-of-care testing regulation, including CLIA waivers, FDA pathways, EU IVDR classification, quality management, and near-patient market trends.

Everything you need to know about IVD device regulations — FDA classification, EU IVDR classes A-D, performance evaluation, companion diagnostics, LDTs, and global regulatory requirements.

How to conduct performance evaluation under the EU IVDR — scientific validity, analytical performance, clinical performance, classification rules, and what Notified Bodies expect.