IVDR consulting services for implementing the IVDR

IVDR consulting services

• Planning or updating IVDR and global IVD submission strategy
• Preparing technical files or pre-submission file reviews to Notified Body expectations.
• Support to write IVDR-compliant technical files. This includes:
  • Training and mentoring staff through files to benefit from our expertise.
  • Providing tools and templates with embedded guidance
• Risk Management training and implementation
• Analytical and Clinical requirements
• Performing Clinical Performance Studies (CPS) including ISO 20916
• Literature searches for Scientific Validity and State of the Art Reports
• Software and IEC 62304 plus AI
• Companion Diagnostics and distance sales
• Post-market surveillance and Post-market follow-up (PMPF)
• Person Responsible for Regulatory Compliance (PRRC) training for manufacturers and economic operators
• Quality Management System (QMS) preparation or updating
• Notified Body audit readiness, incl. training and mock audits
• Understanding and responding to Notified Body (NB) questions
• Training is available on all aspects of the IVDR

Support from IVDR experts

Qserve has built a dedicated IVD team for several years. Our IVDR experts have worked in the industry for start-ups and global players, and some have worked for Notified Bodies at a senior level. This provides Qserve's IVD team with a multi-dimensional perspective of the changes from IVDD to IVDR, what it means to your organization, and the challenges you face.

It's time to change gear. With the proposed extension to transition, our IVDR experts can help you determine where to start revising your strategy and explain what the transition of the IVDR means for manufacturers. Learn how this will impact the conformity assessment process and how you can effectively use the IVDR transition time for successful CE marking. 

Don't hesitate for an orientating conversation. This is a good investment of your time, as strategy is key to effective implementation.

Contact us