In Vitro Diagnostics (IVD) Regulatory Consultancy
IVD manufacturers face a Notified Body backlog, a higher classification bar under IVDR, and FDA submission requirements running in parallel, often for the same product line. Qserve's IVD regulatory consultants manage both tracks so a compliance gap in one market doesn't stall the other.
What does an IVD regulatory consultant do?
What does an IVD regulatory consultant do?
An IVD regulatory consultant manages EU IVDR conformity assessment, US FDA submissions, and post-market obligations for in vitro diagnostic manufacturers. Qserve's IVD team designs analytical and clinical performance studies, builds Technical Documentation to IVDR Annex II and III, and represents manufacturers directly with Notified Bodies and regulatory authorities across the product lifecycle.
When do you need IVD regulatory support?
• Bringing a new IVD, Point-of-Care test, or Companion Diagnostic to the EU or US market for the first time
• Facing Notified Body involvement for the first time after IVDR reclassification
• Running FDA and IVDR submissions in parallel and needing one team managing both
• Lacking an operational post-market surveillance, PMPF, or vigilance process
How does IVD regulatory consultancy differ from medical device consultancy?
IVD regulatory consultancy addresses requirements specific to in vitro diagnostics: IVDR classification rules under Annex VIII, performance evaluation instead of clinical evaluation, and EU reference laboratory involvement for high-risk devices. None of this applies to general medical device regulatory consultancies. Manufacturers running both IVD and device portfolios typically need consultants fluent in both frameworks.
See also IVDR Annex VIII classification rules.
Our IVD services cover multiple disciplines. Discover all of them:
Consultancy
We provide regulatory consultancy support across the entire IVD product development lifecycle, from defining the diagnostic strategy, selecting diagnostic partners, and implementing clinical study processes to post-market activities.
Audits & Assessments
We conduct in-depth audits, gap assessments, and support supplier qualification and audits to ensure compliance with global IVD regulations, including IVDR, FDA QSR, ISO 13485, MDSAP, CAP/CLIA, ISO 15189, and ISO 20916.
IVD Clinical Performance Studies
We design and execute IVD clinical performance studies to demonstrate the accuracy, reliability, and clinical value of your diagnostic device. For stand-alone IVD products and for companion diagnostics (CDx) connected to a drug trial. Our team ensures your study generates robust data to support regulatory approval and long-term success.
QA Support
We support all IVD manufacturers, including Companion Diagnostics manufacturers and laboratories providing testing services, in setting up regulatory-compliant QMS processes.
Regulatory Intelligence
We facilitate expert-driven workshops and strategic dialogues to align stakeholders on regulatory, clinical, and market pathways for all types of IVD, including Companion Diagnostics.
Training
We deliver tailored training programs that use internal expertise on key topics such as global regulatory requirements and developing regulatory strategies, IVDR requirements for clinical evidence and Technical Documentation, IVDD to IVDR transition, implementation of FDA submissions, Discover Qserve Learn, and more training opportunities.
Interim Support
We provide flexible resourcing solutions, such as interim experts, project-based support, or full functional outsourcing, to extend your team's capabilities.
Clinical research
We assist with the clinical strategy, design of analytical and clinical studies, writing the Clinical Performance Study Plan and Report, study submission (US IDE and IVDR CPS authorization), study conduct, and monitoring to generate robust clinical data and ensure regulatory compliance.
Global Market Access
We offer support for both pre-market applications in the U.S. (FDA) and IVDR conformity assessment in the EU. Our services range from authoring submission documents and technical files to selecting a Notified Body, reviewing and gap-remediating technical documentation, and supporting regulatory submissions and meetings with regulatory authorities.
Qserve's IVD consultants bring hands-on industry and Notified Body experience, not just advisory theory. That combination is what shortens the path to conformity assessment and avoids the rework that comes from generic regulatory advice applied to a specific IVD risk class.
Qserve's IVD consultants bring hands-on industry and Notified Body experience, not just advisory theory. That combination is what shortens the path to conformity assessment and avoids the rework that comes from generic regulatory advice applied to a specific IVD risk class.
FAQ
Couldn't find your question?
Do you support both EU IVDR and US FDA submissions in one engagement?
Yes. IVD manufacturers commonly need both running in parallel; Qserve coordinates a single regulatory strategy across both frameworks rather than treating them as separate projects.
How long does IVDR conformity assessment take for an IVD manufacturer?
Timelines depend on device class and Notified Body capacity, which remains the primary bottleneck. Higher-risk IVD classes should plan for Notified Body engagement well ahead of a target market date.
Do you work with IVD start-ups as well as established manufacturers?
Yes, across start-ups, SMEs, and large global manufacturers, scoped to each company's regulatory maturity.
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