Who We Serve: Technology
In Vitro Diagnostics
In vitro diagnostics are regulated as medical devices, but the evidence looks different: reagent stability, lot-to-lot consistency, specimen studies and instructions for use that a laboratory will follow to the letter. We help IVD manufacturers line those records up with their claims before an investigator or notified body tests them.
Standards and Regulations to Know
- ISO 13485Quality Management Systems for Medical Devices
- ISO 14971Risk Management for Medical Devices
- ISO 18113Labeling and Instructions for IVD Medical Devices
- ISO 23640Stability Evaluation of IVD Reagents
- ISO 20916Clinical Performance Studies for IVD Medical Devices
- ISO 15189Quality and Competence of Medical Laboratories
- EU IVDR (Regulation (EU) 2017/746)European Union In Vitro Diagnostic Regulation
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
Typical Regulatory Exposure
In the US, IVDs are medical devices subject to the QMSR and to the premarket pathway for their classification. The clinical laboratories that use them are regulated separately under CLIA, a framework for laboratory testing rather than for manufacturers, which is why a test's complexity categorization matters to your customers without being part of your own quality system obligations.
Several standards shape IVD-specific evidence. ISO 18113 covers the information supplied by the manufacturer with IVD reagents and instruments, ISO 23640 covers stability evaluation of IVD reagents, and ISO 20916 covers clinical performance studies that use specimens from human subjects. ISO 15189 applies to medical laboratories and matters to manufacturers whose customers and study sites work under it. ISO 14971 applies too, with much of the risk sitting in incorrect results rather than direct physical harm.
In the EU, the IVDR replaced the earlier directive with a risk-based classification that brings far more IVDs under notified body review than before. Manufacturers moving from self-declaration face their first notified body audits, a performance evaluation that must be kept current, and post-market surveillance expectations that reach well beyond complaint handling.
Where Audits Find Gaps
- 01
Stability Claims Ahead of the Data
Shelf-life or in-use stability claims rest on accelerated data or a study still in progress, with no recorded plan for confirming them with real-time results.
- 02
Calibrator Traceability Not Documented
Release testing passes lots, but the traceability of calibrators and control materials to reference materials or methods is not documented.
- 03
Instructions for Use That Drift From the Studies
Specimen types, storage conditions or interfering substances listed in the instructions do not match what the analytical studies actually covered.
- 04
Specimen Study Records Incomplete
Clinical performance studies lack documented specimen sourcing, consent or ethics records, or a clear link between the protocol and the final report.
- 05
Erroneous Results Not Treated as Complaints
Customer calls about unexpected or discordant results are handled as technical support, with no evaluation of whether they point to a product problem or a reportable event.
Relevant Standards and Regulations
- ISO 13485Quality Management Systems for Medical Devices
- ISO 14971Risk Management for Medical Devices
- ISO 18113Labeling and Instructions for IVD Medical Devices
- ISO 23640Stability Evaluation of IVD Reagents
- ISO 20916Clinical Performance Studies for IVD Medical Devices
- ISO 15189Quality and Competence of Medical Laboratories
- EU IVDR (Regulation (EU) 2017/746)European Union In Vitro Diagnostic Regulation
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
Relevant Services
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
EU MDR and IVDR Readiness
Prepare your QMS and technical documentation for notified body audits under the EU MDR or IVDR.
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
Supplier Audits and Supplier Controls
Risk-based supplier selection, quality agreements, monitoring and supplier audits that hold up under QMSR.
Audits and Inspections You May Face
EU Notified Body Audit (Including Unannounced Audits)
Conformity assessment, surveillance and unannounced audits by an EU notified body under the MDR or IVDR.
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
ISO 13485 Surveillance Audit
The periodic audits, at least annually, that support continued ISO 13485 certification between renewals.
Questions
Does CLIA apply to us as the manufacturer?
CLIA regulates the laboratories that perform testing, not the manufacturer's quality system. It still matters to you, because the complexity categorization of your test affects which laboratories can run it. Your own quality system obligations come from the device regulations.
We sold under self-declaration in the EU. What changes under the IVDR?
Depending on how your device is classified under the IVDR rules, you may now need a notified body to assess your quality system and technical documentation. That brings conformity assessment audits, surveillance audits and unannounced audits, plus performance evaluation and post-market surveillance documentation the notified body will review.
Do you review our analytical and clinical performance data?
We review whether the studies are documented, controlled and consistent with your claims and labeling. We do not re-run statistics or act as a laboratory. Findings point to where the evidence and the claims disagree.
In Vitro Diagnostics
Get an Advisor's View of Your Quality System
Tell us about your devices and the audit or inspection ahead, and an advisor will scope an assessment for your kind of product. Please don't send confidential documents yet: secure upload is set up after onboarding.
