IVDR Consulting Services for IVD Devices and Software-Driven Diagnostics

Your Trusted IVDR Consulting Partner for Regulatory Success

At QMLogic, we specialize in helping In Vitro Diagnostic (IVD) manufacturers, startups, and software development companies navigate the complex landscape of the EU In Vitro Diagnostic Regulation (IVDR) 2017/746.

Whether your product is a classic IVD device or a software-driven IVD or digital health tool, our IVDR consulting services offer tailored strategies to ensure full compliance, faster market access, and long-term regulatory success.

IVDR Compliance Path: Classic IVD and Software-Driven Devices

IVDR Regulatory Strategy and Notified Body Selection

We support early-stage planning, including defining the IVDR-compliant intended purpose, product classification, and conformity assessment route.

Notified Body (NB) matching based on product codes (IVR 0201, IVR 0202, etc.)
Regulatory strategy tailored to IVDR Annex VIII (classification)
ISO 13485 and ISO 14971 integration planning

We help you match your product scope with the right notified body and prepare a solid regulatory strategy that supports your ISO 13485 and IVDR alignment.

Formal Notified Body Application Support

Navigating NB application processes:

Application form completion
Document package collation
Strategic NB engagement advice

Our consultants assist with completing your NB application precisely and thoroughly, avoiding delays due to documentation gaps.

Partnership Formalization with Notified Body

Agreement signing
Timeline alignment
Document sharing protocols

We support your team in finalizing a compliant agreement and aligning submission timelines for a smooth conformity assessment.

Technical Documentation Development

Your IVDR-compliant Technical Documentation (TD) includes:

Device Description
GSPR Checklist (Annex I)
Performance Evaluation Plan (PEP)
Scientific Validity Report (SVR)
Performance Evaluation Report (PER)
Post-Market Performance Follow-Up (PMPF) Plan
Declaration of Conformity (DoC)
Summary of Safety and Performance (SSP)
Instructions for Use (IFU)

We help compile all the required IVDR technical documentation, including performance evaluation and risk-benefit evidence, in a format ready for NB review.

Notified Body Assessment and Response

Handling questions, feedback, and non-conformities
Expert remediation support

We prepare response strategies for non-conformities and assist in revising your files to meet NB feedback.

On-Site Audit Preparation and Support

QMS and product audit readiness
Mock audits
Documentation alignment for ISO 13485

We guide you through QMS and product audit readiness with mock audits and documentation alignment support.

Certification and Post-Market Activities

Final document set validation
PMS and PMPF implementation
SSP publishing in Eudamed
Re-certification support

Our IVDR consultants support you in finalizing certification and setting up post-market surveillance processes, including SSP publication and PMPF.

IVDR for Software-Driven IVDs

Unique Considerations for Software-Based Diagnostics

Classification under Rule 11
Evidence of performance for algorithm-based solutions
Lifecycle approach for continuous updates
Cybersecurity, data privacy, and interoperability

We specialize in IVDR compliance for Software as a Medical Device (SaMD), including Rule 11 classification and validation strategies for digital diagnostics.

Our IVDR Consulting Packages

We offer modular service packages:

Pre-application Essentials
We help define your intended purpose, assign IVDR-compliant product codes, and prepare for Notified Body engagement.
Clinical Performance Study Planning
We develop your Clinical Performance Study Plan (CPSP) and monitoring strategy, ensuring IVDR and ISO 20916 alignment.
Performance Evaluation Plan & Report
We create a comprehensive strategy (PEP) for collecting clinical and analytical performance evidence and summarize the findings in a robust Performance Evaluation Report (PER).
Scientific Validity Report (SVR)
We justify the link between your analyte and its associated clinical condition, based on literature and biological rationale.
GSPR Checklist & SSP Documentation
We prepare your compliance matrix against IVDR Annex I (GSPR) and write the Summary of Safety and Performance (SSP) for public-facing transparency.
Full Technical Documentation Setup
We guide the creation of your entire Technical Documentation file, including over 40 document types, structured to meet Notified Body expectations.

From early planning to post-market support, our IVDR consulting packages are flexible, transparent, and tailored to your product's risk class and documentation needs.

Why Work With Us?

Over 400 legacy devices transitioned
45+ new IVDs guided through IVDR
Expertise in software and AI/ML-based IVDs
Direct, strategic communication

We are your reliable IVDR consulting company, offering hands-on support for IVD manufacturers and software developers through every regulatory milestone.

Frequently Asked Questions (FAQ)

General IVDR Questions

Q: What is IVDR and how does it differ from IVDD?

A: The In Vitro Diagnostic Regulation (IVDR) replaced the In Vitro Diagnostic Directive (IVDD) on May 26, 2022. IVDR introduces stricter requirements including enhanced clinical evidence, post-market surveillance, unique device identification (UDI), and expanded Notified Body assessment requirements for most device classes.

Q: Which devices require Notified Body assessment under IVDR?

A: Most IVD devices require Notified Body assessment, including Class A sterile devices, Class B, Class C, and Class D devices. Only non-sterile Class A devices can use self-declaration procedures.

Q: What is the difference between classic IVDs and software-driven IVDR?

A: Classic IVDs include traditional laboratory tests, assays, and diagnostic equipment. Software-driven IVDR encompasses digital diagnostics, AI-powered analysis tools, and software medical devices that process diagnostic data. Both require IVDR compliance but software devices have additional requirements under IEC 62304.

Technical Documentation Questions

Q: What documents are included in IVDR Technical Documentation?

A: Technical Documentation typically includes over 30 types of documents covering device description, design and manufacturing information, GSPR compliance, performance evaluation plans and reports, risk management, post-market surveillance plans, and supporting evidence documentation.

Q: How long does IVDR certification typically take?

A: IVDR certification timelines vary based on device complexity and classification. Simple devices may achieve certification in 6-12 months, while complex Class D devices or novel technologies may require 18-24 months. Our consulting services help optimize timelines through efficient documentation and Notified Body coordination.

Q: What is the role of Performance Evaluation in IVDR?

A: Performance Evaluation demonstrates device safety and performance through three components: scientific validity (analyte-condition association), analytical performance (technical measurement capability), and clinical performance (real-world effectiveness). This evidence forms the foundation of IVDR compliance.

Service-Specific Questions

Q: What's included in your consulting packages?

A: Our packages include structured questionnaires, draft document development, review rounds, consulting calls, and stakeholder training. Service levels range from Basic (core documentation) to Premium (express delivery with comprehensive support).

Q: Do you provide ongoing support after certification?

A: Yes, we offer post-market surveillance support, performance monitoring, regulatory update management, and re-certification assistance. Our consulting relationship continues beyond initial certification to ensure ongoing compliance.

Q: Can you support both EU and international registrations?

A: Our primary expertise is IVDR compliance for EU market access. We also provide guidance on international registration strategies and can coordinate with local regulatory experts for global market access.

Software-Driven IVDR Questions

Q: What additional requirements apply to software medical devices under IVDR?

A: Software medical devices must comply with IEC 62304 (software lifecycle processes), implement appropriate cybersecurity measures, demonstrate algorithm validation, and address software-specific risks in addition to standard IVDR requirements.

Q: How do you validate AI/ML algorithms for IVDR compliance?

A: AI/ML validation requires comprehensive training data documentation, performance testing across diverse populations, bias assessment, clinical validation studies, and continuous monitoring procedures. Our consulting services address these specialized requirements.

Q: What is the relationship between ISO 13485 and software medical devices?

A: ISO 13485 quality management systems must address software-specific processes including software development, validation, configuration management, and change control. We help integrate software development practices with quality management requirements.

Q: Do you help with ISO 13485 QMS or ISO 14971 Risk Management?

A: Yes, we have many years of hands-on experience with QMS under ISO 13485 and risk management aligned with ISO 14971. We've supported numerous successful audits and are happy to help in this area as well.

Q: Could you provide support in IEC 62304?

A: Yes, we have helped bring many software-driven IVDs and medical device software (SaMD/MDSW) products to market. We’ll be happy to support you in this area too!