IVD & Diagnostics

A comprehensive guide to the World Health Organization (WHO) prequalification process for medical devices and IVDs, detailing eligibility, step-by-step pathways, and key 2026 procedural updates.

Side-by-side legal-text comparison of IVD registration: FDA 21 CFR Part 809, EU IVDR 2017/746, China SAMR Decree 48, Brazil RDC 830/2023, India MDR 2017 — classes, pathways, who reviews.

Metrological traceability for IVD calibrators and control materials under ISO 17511:2020 and EU IVDR Annex I Section 9.3, covering calibration hierarchies, JCTLM resources, and common pitfalls.

Abbott Libre Duo CE mark analysis covering the first continuous glucose-ketone sensor, dual-analyte regulatory strategy, CGM competition, FDA pathway, and wearable convergence.

Regulatory guide to liquid biopsy and MCED tests, including FDA pathways, Breakthrough designation, companion diagnostics, EU IVDR classification, clinical evidence, and key market players.

Analysis of Thermo Fisher's $1.1B microbiology divestiture to Astorg, including deal terms, Oxoid and Remel assets, $645M revenue, and diagnostics strategy.

Analysis of the IV-to-subcutaneous shift in biologics, covering on-body delivery systems, OBDS combination product pathways, human factors, and market drivers.

Analysis of Abbott's $21B Exact Sciences acquisition, including Cologuard, Oncotype DX, deal structure, cancer screening IVD strategy, and precision oncology market impact.

Guide to EU Reference Laboratories under IVDR Article 100 for Class D IVDs, including rollout, affected categories, performance verification, batch testing, and manufacturer preparation.

How to lock antibody clones, manage lot-to-lot bridging studies, and maintain immunoassay IVD performance across manufacturing campaigns under FDA QMSR, ISO 13485, and EU IVDR.

How to source serum, plasma, urine, CSF, and matrix materials for IVD calibrators and controls, covering donor qualification, viral testing, traceability, lot consistency, and regulatory expectations.

How to establish traceability for IVD calibrators and controls, covering ISO 17511 hierarchy models, reference materials, commutability, uncertainty, value assignment, and regulatory expectations.

Guide to qualifying PCR and RT-qPCR enzyme suppliers for IVD kits, covering Taq polymerase, reverse transcriptase, lot bridging, acceptance specs, stability, change control, and FDA/IVDR expectations.

Prepare an IVD CDMO tech transfer readiness package with manufacturing specs, analytical method transfer, quality agreements, validation roles, and FDA, ISO 13485, and IVDR expectations.

Guide to lyophilized reagent fill-finish for IVD kits, covering formulation, bead and cake formats, humidity control, residual moisture, stability studies, and regulatory documentation.

Guide to qualifying magnetic beads, latex particles, and gold nanoparticles for IVD assays, covering particle specs, conjugation, lot bridging, supplier controls, and regulatory expectations.

Select microfluidic cartridge materials and diagnostic tapes for IVD devices, covering COC, COP, PMMA, PC, PP, bonding, molding, leachables, supplier qualification, and validation.

Select nitrocellulose membranes for lateral flow IVDs using pore size, capillary flow rate, protein binding, backing, lot qualification, and FDA or IVDR expectations.

Qualify oligonucleotide, primer, and probe suppliers for molecular IVD kits with purity specs, lot testing, contamination control, bridging, change notices, and FDA/IVDR expectations.

Analysis of Roche's PathAI acquisition, including AI pathology technology, companion diagnostic strategy, SaMD and IVD regulatory issues, and precision oncology impact.