IVDR services

IVDR services

• Planning or adjusting IVDR and global IVD strategy submissions.
• 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.
• Training
  • IVDR for C-Suite
  • Preparing technical files
  • Risk management
  • Clinical requirements and ISO 20916
  • Literature searches for Scientific Validity and State of the Art Reports
  • Software and IEC 62304 plus AI
  • Companion diagnostic and distance sales
  • Postmarket surveillance
  • Getting ready for NB audits
  • PRRC and economic operators
• Audit readiness
• Understanding and responding to Notified Body (NB) questions
• Preparing technical documentation to support IVDR and FDA requirements

Our IVD team

Qserve has built this dedicated team over the last three years. Our IVDR experts have worked in the industry for start-ups and global players, some have worked for Competent Authorities, or NBs at a senior level. This provides us with a grounded perspective of the changes from IVDD to IVDR and what it means to your organization and the challenges you face.

Qserve has over eighty consultants with a dedicated IVD Team of 10 specialists with experience including:

• Design control
• Risk Management ISO 14971
• Technical documentation and regulatory
• Quality Management Systems, ISO 13485, ISO 15189, MDSAP
• Postmarket surveillance
• Software, AI IEC 62304
• IVDR including Companion Diagnostics and Distance Sales ISO 20916
• FDA PMA, presubmission and denovo 510(k)’s

Contact us