IVD & Diagnostics

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.

Guide to qualifying sample, conjugate, and absorbent pads for lateral flow IVD assays, including material selection, pretreatment chemistry, lot testing, specifications, and QMS controls.

Analysis of CareDx's up to $260M Naveris acquisition, NavDx liquid biopsy technology, TTMV DNA biomarker strategy, transplant-to-oncology pivot, and molecular residual disease market impact.

Analysis of Danaher's $9.9B Masimo acquisition, including deal structure, strategic rationale, antitrust considerations, patient monitoring competition, and medtech industry impact.

Practical guide to the May 26, 2026 IVDR Class C deadline, covering Notified Body applications, the September 2026 agreement milestone, 2028 market access, and key pitfalls.

Design and monitor invalid-result workflows for home-use IVDs, including invalid rates, lay-user errors, repeat testing, IFU comprehension, support scripts, and postmarket trending.

Document NGS bioinformatics pipeline changes, assess validation impact, control software and database updates, and prepare IEC 62304 audit records for IVDs.

Operational guide to converting RUO assays into regulated IVDs, covering claims cleanup, distributor controls, data triage, validation bridging, training, and evidence firewalls.

Plan a CLIA waiver strategy for IVDs, covering complexity categories, CW content, flex and lay-user studies, Dual 510(k) + CLIA Waiver review, timelines, and deficiencies.

Guide to regulatory, privacy, and commercial risks for DTC genetic tests, including FDA oversight, FTC claim substantiation, clinical validity, GINA, state privacy laws, and risk-report claims.

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.