MDR Compliance & CE Certification
Achieve and maintain MDR compliance for your medical devices
The European Medical Device Regulation sets a higher bar for safety, quality, and transparency. Whether you are bringing a new device to market or transitioning an existing one, we guide every step.
The real impact of MDR compliance
MDR compliance is not just about certification. It ensures patient safety, business continuity, and long-term market access.
The European Medical Device Regulation (EU MDR 2017/745) sets a higher bar for safety, quality, and transparency. Whether you are bringing a new device to market or transitioning an existing one, achieving and maintaining MDR compliance requires an integrated approach across Quality Assurance, Regulatory Affairs, and Technical Documentation.
How we support your MDR journey
QbD Group guides you through every step of the MDR process, ensuring smooth, compliant certification.
Quality Assurance
QMS gap assessments, remediation support, mock audits, and supplier audit leadership.
Regulatory Affairs
Regulatory strategy, NB collaboration, PRRC support, and authorized representative services.
Technical Documentation
Address all MDR requirements, compile documentation ready for NB submission.
Clinical evidence
Support in generating clinical evidence and additional studies if required.
Common challenges
Many companies face challenges on their MDR journey:
Stricter regulatory oversight
Evolving interpretations and heightened Notified Body scrutiny demand greater compliance precision.
QMS deficiencies
Gaps in Quality Management Systems can hinder certification and risk product delays.
Higher clinical demands
Increased evidence requirements and ongoing monitoring intensify compliance workloads.
Resource strain
Managing documentation, audits, and submissions places significant pressure on internal teams.
Why QbD Group
Your trusted partner
Partner with QbD Group to confidently tackle MDR challenges and bring your devices to market faster.
10+ years of experience supporting MedTech companies across Europe.
Deep expertise in Regulatory Affairs, Clinical, and Quality disciplines.
Direct collaboration with Notified Bodies and industry associations.
Proven track record in successful CE marking and MDR submissions.
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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.