From FDA to MDR: Your European Market Entry, Simplified
For US MedTech companies with FDA experience entering Europe
For US Medical Device and digital health companies with FDA clearance or regulatory experience, Europe is a natural next step. MDR and IVDR, however, introduce a different regulatory, clinical, and post-market reality.
QbD Group helps US manufacturers translate FDA-based strategies into a predictable, MDR-compliant European pathway. We guide you from EU feasibility and gap assessment through CE marking and long-term compliance.
As your European partner with deep MDR, clinical, and Notified Body expertise, we help you move faster, reduce risk, and avoid costly rework.
Why Europe is challenging for US MedTech companies
Even with FDA clearance, US products don't automatically meet MDR/IVDR requirements. Clinical evidence expectations differ, post-market obligations such as PMCF and vigilance are ongoing, and regulatory approval is decentralized via Notified Bodies.
QbD Group bridges this gap by: aligning FDA-based documentation and clinical data with EU expectations, defining early regulatory and clinical strategies, supporting proactive Notified Body engagement, and coordinating regulatory, quality, clinical, and post-market activities as a single European partner.
Key challenges we address
Regulatory Differences
US FDA logic differs from EU MDR/IVDR requirements, requiring a tailored regulatory approach for European market entry.
Clinical Evidence Requirements
MDR and IVDR demand more extensive clinical data and performance evaluation than FDA alone.
ISO/IEC Compliance
Products must meet EU-recognized standards, including ISO 13485 and related technical and quality requirements.
Notified Body Access
Limited availability of Notified Bodies and heightened scrutiny can delay submissions without proactive planning.
Mandatory EU Roles
Authorized Representative and PRRC obligations must be clearly assigned and maintained for compliance.
Fragmented Execution
Coordinating regulatory, clinical, quality, and post-market activities across Europe is complex and requires integration.
Our structured approach
Regulatory & Technical Documentation
MDR/IVDR classification, CE-marking strategy, technical file creation, GSPR, risk management, usability, and EUDAMED registration.
Clinical Strategy & Operations
CEP/CER development, PMCF planning & execution, real-world evidence, clinical trial execution (CRO role), and medical writing.
Quality Management Systems
ISO 13485 setup & optimization to MDR requirements, audit readiness, supplier quality management, and digital QMS via SciLife.
Software, AI & Digital Health
SaMD & AI-based device guidance, AI Act strategy, cybersecurity requirements, and software lifecycle documentation.
Authorized Representation & Market Entry
EU-REP, UKRP, CH-REP, importer & distributor guidance, and PRRC.
Flexible QA/RA Outsourcing
Interim regulatory roles, QA/RA specialists, and clinical & documentation support.
What you gain
Single European partner
One point of contact for all regulatory, clinical, quality, and post-market needs across Europe.
FDA-to-MDR expertise
Deep experience translating US regulatory strategies into EU-compliant approaches.
Faster time to CE mark
Proactive Notified Body engagement and gap analysis reduce delays and rework.
Why QbD Group
Your single European partner for translating FDA experience into a predictable MDR/IVDR-compliant pathway.
FDA-to-MDR translation expertise
deep experience converting US regulatory strategies, clinical data, and documentation into EU-compliant submissions
Proactive Notified Body engagement
we prepare your technical file and clinical evidence to meet heightened EU scrutiny from day one
Integrated EU market entry services
regulatory, clinical, quality, post-market, and authorized representation under one roof
First-time-right approach
structured gap analysis and documentation strategies that reduce rework and accelerate CE marking timelines
Scalable partnership
from strategic advisory through full operational support, adapting to your project stage and ambitions
FAQ
Frequently asked questions
Talk to a EU MedTech Expert
Fill out the form, and our team will guide you on regulatory strategy, clinical evidence, CE marking, and quality alignment to ensure a smooth European market entry.