Industries
IVD & Diagnostics
Diagnostics sit between device quality system requirements and laboratory practice. We support IVD manufacturers and laboratory-developed test operations with systems that address both.
xFDA supports in vitro diagnostics manufacturers and diagnostic laboratories with quality management systems, assay design control and verification/validation, reagent lifecycle management, manufacturing and kitting controls, laboratory data integrity and complaint handling.
How we support this sector
Where engagements typically focus
- Quality management systems for IVD manufacturers
- Design control and verification/validation for assays and instruments
- Reagent, calibrator and control material lifecycle management
- Manufacturing and packaging controls, including kit assembly
- Analytical performance documentation and method transfer
- Complaint handling, corrections and removals
Engagements frequently combine device quality system work with laboratory compliance and data integrity support.
When companies call us
Situations we are asked into
- An assay developed in a laboratory environment now has to be manufactured under a device quality system.
- Lot-to-lot variability in calibrators or controls is being handled as a series of one-off investigations.
- Instrument software changes are released without documented verification.
- Kit assembly and labeling errors are reaching customers.
- A diagnostic laboratory needs its data practices to withstand technical scrutiny.
Diagnostics sub-practice
IVD & Diagnostics: how we work in this sector
IVD and diagnostic companies sit between device quality expectations and laboratory science. xFDA supports quality systems, design and verification documentation, manufacturing transfer and supplier control for diagnostics — including companion diagnostics and laboratory-developed testing operations — with consultants who have worked on both the assay and the compliance side.
IVD quality systems
Right-sized quality systems for diagnostics companies moving from development into commercial manufacturing.
- Quality system build and QMSR alignment for IVD manufacturers
- Document and design control implementation
- Reagent and critical component supplier control
- Lot release and specification governance
- Training and competency for laboratory-based operations
Verification, validation & performance evidence
Study documentation that supports the intended use claim, not just the science behind it.
- Analytical verification protocol and acceptance criteria review
- Clinical/performance study documentation structure
- Method and assay transfer between sites
- Software and data handling controls for assay outputs
- Change assessment against verified performance
Manufacturing & scale-up quality
The point at which most diagnostics companies discover their documentation was written for a development team.
- Development-to-manufacturing transfer packages
- Process controls and in-process specification setting
- Reagent lot history and traceability
- Contract manufacturer and supplier oversight
- Companion diagnostic quality coordination with the drug sponsor
Typical engagements
Pre-study documentation review
Alignment of intended use, protocol, acceptance criteria and record structure before analytical or clinical performance studies are executed.
Scale-up quality readiness
Specification, control and release-criteria work at the transfer from development into routine diagnostic manufacturing.
IVD Quality & Documentation Review
A focused review of your diagnostic quality system, verification documentation and manufacturing transfer readiness by consultants who have done this work in diagnostics.
Expert Answers
IVD & Diagnostics: answered by our consultants
- When should an IVD company bring in outside regulatory or quality support?Before the first submission-supporting study is designed, and again at the point of scale-up. Diagnostic companies most often need help when analytical and clinical performance work has been executed well scientifically but documented in a way that does not support a regulatory claim.
- How much quality system does a growing diagnostic company actually need?Enough to control the records that a future submission and a future inspection will depend on — document control, design control, supplier control and training — and no more than the current headcount can sustain.
Questions we are asked
IVD & Diagnostics: common questions
Direct answers from the consultants who do this work.
- How does IVD quality system work differ from other device work?
- IVDs combine device quality system requirements with analytical performance obligations. The quality system has to control reagent formulation, calibrator and control value assignment, stability, and instrument-assay interaction — areas a generic device quality manual usually does not address.
- What documentation supports analytical performance claims?
- Pre-defined protocols and reports covering precision, linearity, detection limits, interference, matrix comparison and stability, with traceability from raw data to the claims in labeling. Method transfer between sites needs the same rigor.
- How should reagent lots be released?
- Against pre-approved specifications with defined acceptance criteria for identity, potency, functional performance and stability, using reference materials that are themselves controlled. Trending across lots should be a formal quality activity, not an informal spreadsheet.
- Do you support laboratory-developed test operations?
- We support the quality and data integrity practices behind LDT operations — method validation records, instrument qualification, data controls and investigation practice. We do not offer legal opinions on evolving LDT regulatory status.
- What triggers a correction or removal decision?
- Evidence that distributed product may not perform as labeled. The important system element is a documented, consistently applied evaluation process with defined decision authority and timelines, so the decision does not depend on who happens to review the complaint.
Technical guidance for this sector
- QMSR TransitionThe Quality Management System Regulation incorporates ISO 13485 into FDA's device quality system requirements.
- ISO 13485ISO 13485 defines a quality management system for organizations involved in the medical device lifecycle.
- Process ValidationDevice manufacturers must validate any process whose results cannot be fully verified by subsequent inspection and test.
- CAPACAPA is the system FDA examines first in a device quality system, because it reveals whether the organization detects and fixes its own problems.
- Supplier QualityPurchasing controls make you responsible for the quality of what others make for you.
- 510(k) SupportA 510(k) is an argument for substantial equivalence, supported by evidence your quality system has to be able to produce on demand.
- PMA SupportA PMA is reviewed alongside a pre-approval inspection of the manufacturing site, which means the manufacturing section is not paperwork — it is a description of a facility that will be examined.
- De Novo SupportA De Novo asks FDA to create a classification, which means the submission has to propose the controls that will make the device type safe and effective.
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