IVD services

Regulatory
strategy support

• Global regulatory strategy
• Planning or adjusting EU-IVDR
• Global IVD strategy submissions
• US FDA pre-submissions, IDE, denovo, 510(k), PMA, CDx significant risk determinations
• Device/system qualification and classification rationalization
• Conformity assessment route identification
• Notified Body selection and communication
• Competent Authority communication

Technical Documentation Support

• Preparing technical documentation to support IVDR and FDA requirements
• GSPR, Declaration of Conformity
• Clinical and Performance Evaluation
• Design Control, assay development, software
• Risk Management
• Biocompatibility
• Sterilization, Shelf life, Packaging
• Electrical safety, EMC
• Usability, Labeling, IFU, Symbols

Quality Management System Support

• Quality Manual
• Quality Management System (SOPs, templates etc.) 
• Internal Audits, Mock Audits
• IVDR Annex IX, ISO 13485, ISO 15189. ISO 20916
• Management Review
• QMS gap assessments 

Companion Diagnostics (CDx) 

• IVDR pertaining to CDx
  • Performance study design, plans, reports, In-house tests = distance sales = exemptions
  • Conformity assessment route to CE Mark (Class C)
  • Notified Body process
  • FDA IDE and significant risk determination
• Annex XIII and Annex XIV
  • Guidance and interpretation, gap assessments and remediation
  • Write Clinical Performance Study Plans (CPSP) and Reports
• Clinical Trial Assay (CTA) - used in early Pharma studies
  • Advise on requirements and process per country, draft clinical performance protocol
  • Bridging study design

Quality and additional services

• Post Market Surveillance
  • Process development
  • PMS and PMPF plans and reports
• Auditing – QMS development, gap assessment, remediation
  • IVDR Annex IX, ISO 13485, ISO 15189, ISO 20916, MDSAP
• Risk Management – training, process development, gap assessment, remediation
  • ISO 14971 training and workshops
  • Process development and risk mgmt. execution

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

Learn more about the IVD training sessions.

Training