Industries We Serve
IVD & Diagnostics Regulatory & Quality
Regulatory strategy and quality systems for in vitro diagnostics, assays, analyzers, and diagnostic software.
Overview
In vitro diagnostics live or die on validation evidence. The device may never touch a patient, but its result drives a clinical decision — so regulators scrutinize analytical performance, clinical performance, and the software that turns a signal into a call. The IVD profile is distinct: risk classification follows the consequence of a wrong result, EU IVDR has up-classified the majority of assays into notified-body review, and CLIA complexity shapes how and where the test can be run. Getting the intended-use statement, the claims, and the validation plan aligned early is what keeps an IVD program from stalling in review.
FDA Pathway & Classification
Most IVDs in the US fall under Class II and clear via 510(k) against a legally marketed predicate, with the intended use and analyte-specific claims defining the comparison. Novel diagnostics with no predicate route through De Novo, which establishes a new classification and the special controls that follow it — increasingly the path for first-of-kind molecular and companion-diagnostic-adjacent assays. High-risk tests, including most companion diagnostics tied to a therapy and many Class III assays, require PMA with a full clinical performance dataset. A Pre-Submission is the highest-leverage step for IVDs: it locks intended use, predicate or De Novo strategy, and the analytical/clinical study design with FDA before money is spent on the pivotal study. In the EU, IVDR (2017/746) has up-classified the field into Classes A through D, pulling the large majority of assays into conformity assessment by a notified body — a structural change from the old IVDD self-declaration regime that catches many legacy products off guard. CLIA complexity categorization (waived, moderate, high) is determined separately and shapes the deployment claim, not the clearance itself.
Quality & Risk
An IVD QMS is built on ISO 13485 with the diagnostic-specific muscles fully developed: design controls that trace every claim to a validation result, ISO 14971 risk management framed around the harm of a false positive or false negative rather than direct device contact, and design verification and validation evidence covering analytical sensitivity and specificity, precision, linearity, interference, cross-reactivity, matrix effects, and reference-interval or cutoff establishment. Clinical performance — sensitivity, specificity, and predictive values against a defined comparator — has to be planned as rigorously as the analytical work. Software is rarely optional in modern diagnostics: instrument firmware, algorithm-driven result calls, and standalone SaMD all demand IEC 62304 lifecycle controls, documented software risk analysis, and validation tied to intended use. Where the device contacts the patient or a specimen path raises exposure concerns, ISO 10993 biocompatibility applies to the sample-contacting components, and sterilization and ISO 11607 package and shelf-life validation come into play for sterile collection devices and consumables. The IVDR technical file and performance evaluation report pull all of this — analytical performance, clinical performance, and scientific validity — into a single evidence chain that a notified body will test line by line.
In-Family Testing
Diagnostic programs draw on the full Boulder family for the bench data regulators expect. Boulder BioLabs supports the microbiology and analytical work behind assay validation, residuals testing on consumables, and biocompatibility coordination for specimen- and patient-contacting components under ISO 10993. Boulder Sterilization runs EO and chlorine dioxide cycles for sterile collection devices, swabs, and single-use consumables, with the cycle and residuals data that feed the regulatory file. Boulder Package Testing validates the sterile barrier and shelf life of diagnostic kits and consumables to ISO 11607, including accelerated and real-time aging. Boulder iQ brings the engineering and manufacturing depth for analyzers, cartridges, and fluidic consumables — so design transfer and process validation hold up under audit. We coordinate the testing so the evidence lands in the technical file the way a reviewer reads it.
We Live It, Not Just Advise It
We run an FDA-registered operation under our own ISO 13485 quality system — the same controls we build for IVD clients, we operate every day. We’ve sat on both sides of the submission and the audit, so we write intended-use statements and validation plans the way reviewers actually read them, not the way they look good on a slide.
Frequently Asked Questions
How is the FDA pathway for an IVD decided — 510(k), De Novo, or PMA?
It comes down to risk and predicate. If a legally marketed device with the same intended use exists, you compare to it under 510(k) — the most common IVD path. If your test is genuinely novel with no predicate but low-to-moderate risk, De Novo creates a new classification with its own special controls. High-risk tests, including most companion diagnostics tied to a therapy decision, require PMA with a clinical performance dataset. We settle this in a Pre-Submission so FDA agrees on the classification and study design before you run the pivotal trial.
Why is EU IVDR a bigger deal than the old IVDD for my assay?
Under the former IVDD, the large majority of assays were self-declared with no notified body involved. IVDR replaced that with a risk-based Class A through D scheme that pulls most tests into notified-body conformity assessment. In practice that means a full technical file, a performance evaluation report covering scientific validity plus analytical and clinical performance, and ongoing post-market performance follow-up. Legacy products that coasted under IVDD now need a real evidence package — and that’s the work that surprises teams the most.
My diagnostic relies on an algorithm to call results — what software requirements apply?
Any software that interprets a signal into a clinical result is regulated, whether it’s instrument firmware, an embedded algorithm, or standalone SaMD. You need an IEC 62304 software lifecycle, documented software risk analysis tied to your ISO 14971 file, and verification and validation traced to intended use. If the algorithm changes the result a clinician acts on, regulators treat it as a core part of device performance — not an accessory — so it has to be validated and controlled with the same rigor as the assay chemistry.
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One campus, one quality system. We manufacture, sterilize, and test medical devices in-house — so our regulatory and quality work is grounded in operations, not theory.