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
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.
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
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.
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.
Why Work With Us?
We are your reliable IVDR consulting company, offering hands-on support for IVD manufacturers and software developers through every regulatory milestone.
- Over 400 legacy devices transitioned
- 45+ new IVDs guided through IVDR
- Expertise in software and AI/ML-based IVDs
- Direct, strategic communication
Frequently Asked Questions (FAQ)
General IVDR Questions
Technical Documentation Questions
Service-Specific Questions
Software-Driven IVDR Questions
Connected Services
QMS Digitalization & Automation
Implement ISO 13485-compliant processes using Jira, Confluence, and SharePoint.
At QMLogic, we empower organizations to revolutionize their Quality Management Systems (QMS) with cutting-edge automation tools. Our expertise spans Microsoft SharePoint, Power Platform, Confluence, Jira, and custom-built solutions tailored to specific needs.
- Future of Quality Management
Medical Device Software Development (SaMD/MDSW)
Medical Device Software Development
QMLogic delivers trusted medical device regulatory consulting services and medical device regulatory compliance software support, guiding you from development to successful certification.
- Regulatory Compliance
