Europe

Qserve EU-IVDR Services

 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

EU-IVDR Compliance

Implementing the IVDR requires a structural approach. Transitioning companies to full IVDR compliance, including new certificates for up to 90% of product portfolios, will span several years.

The uncertainties which follow the introduction of the IVDR can be minimized by implementing Qserve’s EU-IVDR roadmap, which can be tailored to the specific needs of manufacturers.

 

 

 

Qserve Group, Global reach, local service.

Qserve's practical approach supports clients' needs from quality systems to product development and clinical trials, through market approvals. Our philosophy customizes the strategy to meet the needs of companies in the most efficient and cost effective manner. Qserve, your global partner for regulatory, clinical and quality services.

 

 

Qserve Roadmap implementation steps

Scope & Plan: A quick scan of critical impact elements. The plan defines scope, timelines, methods, resources, structures, and tools. Check also the Qserve app.
GAP Assessment: will include device, clinical and QMS related issues, addressing all aspects of the MDR.
Portfolio Rationalization: This plan will outline the strategies per device family including cost breakdown.
Global Impact Analysis: The impact on your global registrations can be significantly and the Global Impact Analysis will help as a basis for discussions.
Master Compliance Roadmap: The business organizational structure of the manufacturer and the plan with charters, will be designed.
Regulatory Training: Training ensures that employees are properly aligned with the new regulations. We offer In Vitro Diagnostic Device Regulation training.
Implementation of Roadmap: The charters have a charter definition sheet with objectives, budget, milestones team members and follow a standardized working method.
Effectiveness Check: The verification of the project charters output is an effectivity check.
EU-MDR Compliance: The final check for compliance with the MDR will be performed by your Notified Body.

Want more information? Get in touch with us

Information request