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Consulting for IVD manufacturers: IVDR compliance, performance evaluation, and marketing authorization for diagnostic devices.

The in vitro diagnostics industry is facing enormous regulatory pressure: The IVDR (2017/746) has significantly tightened requirements for performance evaluation, clinical evidence, and post-market surveillance. ENTOURAGE supports IVD manufacturers from product development through to post-market surveillance.

In-vitro diagnostics and IVDR compliance: consulting for IVD manufacturers
+500
Successful IVD and
diagnostics projects worldwide
100%

's success rate in IVDR certifications
Top 10
Leading IVD manufacturers—
—trust our expertise
How does consulting for IVD manufacturers ensure market access under the IVDR?
The European IVDR (2017/746) requires diagnostic manufacturers to adopt a new approach to clinical evidence and performance evaluation. Consulting services for IVD manufacturers help companies systematically address the significantly increased requirements for Performance Evaluation Reports (PER), analytical and clinical performance studies, and the reclassification of their product portfolios. Structured support from experts accelerates the approval of complex products—such as companion diagnostics (CDx) or software-as-a-medical-device (SaMD)—and ensures post-market compliance.

What challenges will shape the IVD industry in 2026?

The in vitro diagnostics industry is undergoing the most profound regulatory transformation since the introduction of the IVDD. This is creating concrete operational challenges for IVD manufacturers:

  • The IVDR transition requires the reclassification of all IVD products—many manufacturers underestimate the effort involved for higher-classified products
  • There are very few notified bodies for IVDs—long wait times and strict requirements for technical documentation
  • Performance evaluation under the IVDR requires significantly more extensive clinical evidence than under the IVDD—especially for Classes C and D
  • Companion diagnostics (CDx) must be coordinated with drug development from a regulatory perspective—a complex, multi-stakeholder process
  • A shortage of IVDR-specialized regulatory affairs managers and clinical evidence experts is slowing down certification projects
  • EUDAMED registration and UDI assignment for the entire IVD portfolio entail a significant administrative burden
"The IVDR has fundamentally changed the rules of the game for in vitro diagnostic medical devices. Many manufacturers now face a decision: streamline their portfolio or invest. Those who set the right regulatory course early on will secure market access—those who hesitate risk supply shortages."
– Dr. Jennifer Neff, Vice President of Medical Devices & IVD, ENTOURAGE
Ivd consulting services: ivdr compliance, performance studies, and performance evaluation

Our IVD consulting services.

We combine in-depth regulatory knowledge with diagnostic expertise to provide comprehensive support to IVD manufacturers.

IVDR Compliance & Classification
Classification in accordance with IVDR Annex VIII, gap analyses of existing technical documentation, conformity assessment procedures, and support during audits by Notified Bodies. Transition strategies for the transition from the IVDD to the IVDR.
Performance Evaluation & Clinical Evidence
Performance evaluation plans, analytical and clinical performance studies, scientific validity reports, and the preparation of performance evaluation reports (PER) in accordance with the IVDR.
Companion Diagnostics (CDx)
Regulatory strategies for companion diagnostics in coordination with drug development. Coordination among IVD manufacturers, pharmaceutical companies, and regulatory agencies (EMA, FDA).
QMS & Post-Market Surveillance
ISO 13485 QMS Implementation and Optimization for IVD Manufacturers. Post-market surveillance, vigilance systems, trend reporting, and PSUR preparation in accordance with the IVDR.
Regulatory Affairs & FDA (IVD)
Market authorization strategies for the EU (IVDR) and the U.S. (FDA 510(k), PMA, De Novo for IVDs). EUDAMED registration, UDI assignment, and interactions with health authorities.
Software & Digital Diagnostics
Software as a Medical Device (SaMD) for diagnostic applications, IEC 62304 compliance, AI-based diagnostics, and cybersecurity requirements according to IEC 81001-5-1.

Our expertise in the IVD industry.

ENTOURAGE covers the entire IVD lifecycle through six specialized expertise clusters—from assay development to post-market surveillance.

Cluster 1

Regulatory & Compliance

IVDR compliance, CE marking, FDA approval, classification, and post-market surveillance for in vitro diagnostic medical devices.

GMP · Annex 1 · FDA · ATMPs · Health Authority Cluster 2

Quality Management

ISO 13485 quality management systems, CAPA management, internal audits, supplier qualification, and continuous improvement for IVD manufacturers.

CAPA · Deviations · ISO 9001 · GLP · Lean Six Sigma Cluster 3

Clinical and Medical Affairs

Performance Studies, Clinical Performance Evaluation, Scientific Validity, Companion Diagnostics, and Clinical Evidence Management.

GCP · CRO · Pharmacovigilance · CMC · PMCF Cluster 4

R&D & Engineering

Assay development, design controls, verification and validation, software development (IEC 62304), and risk management (ISO 14971).

V&V · Feasibility · Biocompatibility · Prototyping Cluster 5

Manufacturing & Supply Chain

Production transfer, lean manufacturing, supplier qualification, packaging validation, and supply chain governance for IVD.

CAPEX · GDP · Lean · Scale-up · Procurement Cluster 6

Business Data Solutions & IT

Software as a Medical Device (SaMD), AI-based diagnostics, EUDAMED, UDI implementation, and digital health compliance.

CSV · ALCOA+ · Part 11 · ERP · ISO 27001

Why IVD manufacturers use ENTOURAGE.

What sets us apart from traditional management consultancies and individual consultants:

ENTOURAGE Major consulting projects Freelancer
Industry Focus 100% Life Sciences Across all industries A single niche
Implementation On-site operations More of a strategic move Hands-on, individual
Team size 200+ consultants, scalable Large teams available individual
Level of regulation GxP, FDA, EMA, ICH Generalist In a niche of its own
Flexibility Project contract or framework agreement Long contract terms Daily

Successful IVD projects.

Our case studies demonstrate how ENTOURAGE supports IVD manufacturers with IVDR transition, performance evaluation, and marketing authorization.

IVDR Transition for a Portfolio of Over 200 IVD Products
Challenge: A medium-sized IVD manufacturer needed to reclassify and recertify its entire portfolio of over 200 products within the IVDR transition periods.

Measures: Portfolio screening and risk prioritization, reclassification of all products, gap analyses of technical documentation, performance evaluation reports, and support during Notified Body audits.

Result: Timely IVDR compliance for all prioritized products. Notified Body audit passed without major findings.
Performance Study Design for Class D Companion Diagnostics
Challenge: An IVD manufacturer developed a Class D companion diagnostic (CDx) and required a strategy for performance studies and parallel coordination with the pharmaceutical company.

Actions: Clinical performance study design, coordination with the drug manufacturer, scientific validity report, preparation of technical documentation, and pre-submission to the Notified Body.

Result: Successful performance study with sufficient clinical evidence. Positive feedback from the Notified Body. CDx application submitted in parallel with the drug application.
FDA 510(k) for a novel point-of-care test
Challenge: An IVD startup wanted to bring a novel point-of-care rapid test to the U.S. market and needed an FDA approval strategy.

Actions: Regulatory pathway analysis (510(k) vs. De Novo), predicate device research, analytical and clinical performance studies, pre-submission meeting with FDA CDRH.

Result: 510(k) clearance on first submission. Time-to-market reduced by 5 months. Successful pre-submission interaction with FDA CDRH.

Frequently Asked Questions About Consulting Services for IVD Manufacturers.

What regulatory requirements for IVDs does ENTOURAGE cover?
We cover the entire regulatory spectrum for IVDs: IVDR (2017/746), FDA clearances (510(k), PMA, De Novo), ISO 13485, ISO 14971, IEC 62304, and IVDR-specific Common Specifications. Our consultants have an average of 10+ years of IVD experience.
Does ENTOURAGE support companion diagnostics?
Yes, companion diagnostics (CDx) are one of our areas of expertise. We coordinate regulatory alignment between IVD manufacturers and pharmaceutical companies, plan performance studies, and support parallel marketing authorization with the EMA and FDA.
How does ENTOURAGE support the transition to the IVDR?
We provide support throughout the entire IVDR transition process: portfolio screening and reclassification, gap analyses of technical documentation, preparation of performance evaluation reports, EUDAMED registration, and support during Notified Body audits.
What sets ENTOURAGE apart from traditional management consulting firms?
ENTOURAGE is not a traditional strategy consulting firm. Our consultants are trained scientists, regulatory affairs experts, and quality managers with in-depth IVD expertise. We work directly on your projects—from assay development through to regulatory approval.
Can ENTOURAGE assist with FDA approvals for IVDs?
Yes. We assist with 510(k), PMA, and de novo approvals for IVDs with the FDA. Our experts provide support for predicate device analysis, pre-submission meetings, and the preparation of FDA submissions for diagnostic products.
How does ENTOURAGE support performance studies?
We plan and support analytical and clinical performance studies in accordance with the IVDR. Our services range from study design and implementation to statistical analysis and the preparation of the Performance Evaluation Report (PER). We place a special focus on Class C and D devices.
What experience does ENTOURAGE have with IVDR reclassification?
We have guided over 500 IVD products through the IVDR reclassification process. Our experts are familiar with the requirements for all risk classes (A through D) and provide support in preparing technical documentation in accordance with IVDR Annexes II and III.

Your contacts for IVD.

Talk directly to our industry experts—we’ll connect you with the right team.

Dr. Jennifer neff
Dr. Jennifer Neff
Vice President Medical Device

Strategic leadership and technical responsibility for all medtech and IVD projects. IVDR, FDA, and ISO 13485.

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Julia Beck
Julia Beck
Head of MedTech Sales

Your first point of contact for project inquiries, framework agreements, and customized consulting packages in the medtech and IVD sectors.

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Talk to our IVD experts.

Whether it's IVDR transition, performance evaluation, or marketing authorization—we'll find the right solution for your project.

Ensuring project success in in vitro diagnostics.

Briefly describe your project, and we’ll assign an experienced team of IVD consultants to assist you within 24 hours.