Life Cycle Management
End-to-end product lifecycle support
Keep your medical devices and IVDs compliant, safe, and competitive throughout their entire lifecycle. QbD Group provides comprehensive lifecycle management covering post-market surveillance, design changes, re-certification, and ongoing regulatory compliance under MDR and IVDR.
From PMCF/PMPF studies and vigilance reporting to technical file updates and notified body interactions, we manage the technical and regulatory complexities of your device portfolio so your products remain available to patients and fully aligned with evolving European standards.
Comprehensive device lifecycle management
QbD Group's MedTech lifecycle management solution ensures your devices remain compliant and commercially viable from initial certification through end-of-life. We combine regulatory expertise, quality management, and post-market capabilities to support every stage of the product lifecycle.
Our support spans PMS system implementation, PMCF/PMPF planning and execution, vigilance reporting, technical file maintenance, design change management, and notified body interactions — providing both recurring operational support and specialized consultancy for your device portfolio.
Key challenges we address
MDR/IVDR transition
Managing the transition to MDR and IVDR while maintaining market access requires sustained effort in re-classification, documentation updates, and notified body interactions.
Post-market obligations
Increasing PMS, PMCF/PMPF, and vigilance requirements demand continuous monitoring and proactive compliance management.
Design change complexity
Managing design changes, risk reassessments, and technical file updates while maintaining CE certification and notified body alignment.
Our structured approach
Portfolio Assessment
Evaluate your device portfolio against current MDR/IVDR requirements, identify gaps, and prioritize actions.
Design Change Management
Manage design changes, risk assessments, and documentation updates while maintaining certification status.
Post-Market Surveillance
Implement robust PMS, PMCF/PMPF, and vigilance systems that satisfy MDR/IVDR requirements.
Re-certification & Renewals
Navigate notified body interactions, certificate renewals, and regulatory submissions for continued market access.
Our integrated offerings
Our integrated offerings support organizations across their full operational lifecycle, from compliance activities to sustained control, improvement, and digital enablement.
Comprehensive device lifecycle support
From PMS and vigilance to technical file maintenance and re-certification — we keep your devices compliant under MDR/IVDR.
What you gain
Sustained market access
Proactive lifecycle management ensures uninterrupted market access under evolving MDR/IVDR requirements.
Regulatory confidence
Expert management of design changes, PMS obligations, vigilance reporting, and notified body interactions.
Operational efficiency
Streamlined lifecycle processes that reduce internal burden while maintaining full compliance across your device portfolio.
Why QbD Group
Your dedicated partner for keeping medical devices and IVDs compliant, safe, and commercially viable throughout their entire lifecycle under MDR and IVDR.
Deep MDR/IVDR lifecycle expertise
hands-on experience with PMS, PMCF/PMPF, vigilance, and technical file maintenance across all device classes
Seamless transition support
re-classification, documentation updates, and notified body interactions for legacy devices moving to MDR/IVDR
Design change management
risk reassessment, technical file updates, and certification maintenance when your product evolves
Integrated post-market services
PMS system implementation, vigilance reporting, PSUR preparation, and trend analysis under one program
Sustained market access
proactive management of certificate renewals, notified body interactions, and regulatory submissions
How we support your device lifecycle
QbD Group ensures your devices remain compliant and commercially viable from certification through end-of-life
Post-Market Surveillance & Vigilance
Continuous monitoring and safety compliance.
- PMS system implementation
- PMCF/PMPF planning and execution
- Vigilance reporting and trend analysis
Technical File & Regulatory Maintenance
Keep documentation current and compliant.
- Technical file updates
- Design change impact assessment
- Notified body interaction management
FAQ
Frequently asked questions
Need medical device lifecycle support?
Partner with QbD Group for comprehensive MDR/IVDR lifecycle management — from PMS and vigilance to technical file maintenance and re-certification.