IVDR consulting services for implementing the IVDR

Qserve is here to support you with all your EU IVDR implementation needs

How can Qserve help you?

IVDR consulting services for implementing the IVDR

Implementation of any new regulation is always a rollercoaster ride, and we know exciting times are ahead! We also understand you are a global business, and the in vitro diagnostic regulation (IVDR) may have implications for other submissions, presenting both opportunities and threats. Qserve is here to support with our IVDR consulting services for implementing the IVDR.

How to prepare for the new IVDR?

Our IVDR experts can help you determine where to start. They fully understand the key changes from IVDD to IVDR, the re-classification, and the new transitional arrangements. Don't hesitate for an orientating conversation. This is a good investment of your time, as strategy is key to effective implementation.

https://www.qservegroup.com/write/Afbeeldingen1/IVDR/540-ivdr-website.jpg?preset=content

Contact

IVDR consulting services

Qserve supports customers at all points on their journey with the following IVDR consulting services for implementing the IVDR:
  • Planning or updating IVDR and global IVD submission strategy
  • IVDR strategy discussion with C-Suite
  • 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 gain the benefit from our experts, including tools and templates
  • 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)
  • Training for the Person Responsible for Regulatory Compliance (PRRC) for manufacturers and economic operators
  • Quality management system (QMS) preparation or updating
  • Notified Body audit readiness, including training and mock audits
  • Understanding and responding to Notified Body (NB) questions
  • Training is available on all aspects of the IVDR

Our IVD team

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.

Qserve has over eighty consultants with a dedicated IVD Team with experience, including:

  • Design control
  • Risk Management ISO 14971
  • Technical documentation and regulatory submissions
  • Quality Management Systems, ISO 13485, ISO 15189, MDSAP
  • Postmarket surveillance and PMPF
  • Software, AI IEC 62304
  • Companion Diagnostics and Distance Sales
  • Clinical Performance Studies including ISO 20916
  • Generating technical documentation to support both the IVDR plus FDA PMA, presubmission and denovo 510(k)’s

Contact us


IVDR consulting services to support the complete Design and development process

https://www.qservegroup.com/write/Afbeeldingen1/IVDR/In-Vitro-Process-new-version-JPG.jpg?preset=content

Interested in our global IVDR consulting services for implementing the IVDR?

We want to help you with the challenges you might have designing devices for multiple markets, changing or setting up your market access strategy to comply with the IVDR or start preparing appropriate regulatory submissions for the US.

Contact us