Regulatory Affairs for Medical Devices
Strategic regulatory support from classification to market
Bring safe, compliant medical devices to market faster with strategic regulatory support tailored to your technology. From classification to submission, we guide every step.
Regulatory Expertise
Your regulatory partner for Medical Devices
Navigating MDR and IVDR requires deep regulatory knowledge and hands-on experience. QbD Group supports medical device manufacturers at every stage — from early classification decisions to Notified Body certification and beyond.
Full MDR & IVDR Coverage
From product classification and regulatory strategy through technical documentation, CE marking, and post-market surveillance — we cover the full regulatory lifecycle under MDR and IVDR.
Notified Body Readiness
We prepare your documentation and quality systems to meet Notified Body expectations, reducing review cycles and avoiding costly delays in the certification process.
Integrated Regulatory & Clinical Expertise
Our regulatory consultants work hand-in-hand with clinical and quality teams, ensuring your regulatory strategy is fully aligned with clinical evidence requirements and QMS standards.
Flexible Engagement Models
Whether you need a single regulatory deliverable or ongoing support across your entire portfolio, we adapt to your needs — acting as a seamless extension of your team.
Experience
600+
Specialists
Across regulatory, clinical & quality
500+
MD & IVD projects
Successfully delivered
15+
Years experience
In EU medical device regulation
30+
Countries
Served across Europe and beyond
Offerings
What we offer20
Our Approach
Why partner with QbD Group for Medical Devices?
We combine deep regulatory knowledge with practical experience across all medical device classes and technologies — delivering strategic, compliant, and commercially focused solutions.
First-time-right approach
We focus on getting your regulatory submissions right the first time — reducing review cycles, avoiding rework, and accelerating your path to CE marking.
European market expertise
With deep knowledge of MDR, IVDR, and the European regulatory landscape, we help you navigate Notified Body expectations and member-state requirements with confidence.
End-to-end documentation
From technical files and clinical evaluation reports to PSUR and PMS plans, we deliver comprehensive documentation that meets the highest regulatory standards.
Collaborative partnership
We work as an extension of your team — providing senior regulatory expertise on demand, scaling up or down as your project needs evolve.
Why QbD Group
Your trusted partner
QbD Group's Regulatory Affairs team combines deep industry expertise with a pragmatic, hands-on approach. We help life sciences companies navigate complex European regulatory landscapes efficiently — from initial strategy through post-market compliance.
Cross-industry expertise
our regulatory specialists cover Pharma, Biotech, Medical Devices, IVD, and Combination Products under one roof.
Strategic regulatory planning
we align your regulatory pathway with commercial objectives to accelerate time-to-market.
Proven track record
with thousands of successful submissions and dossier management projects across Europe, we deliver results you can count on.
Scalable support
from a single regulatory question to full outsourced regulatory operations, we adapt to your needs.
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Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.