1 CDX REGULATORY STRATEGY DEVELOPMENT

• Regulatory Pathway Analysis (FDA CDRH, CBER, CDER)

• Pre-Submission (Q-Sub) meeting preparation & direct FDA consultation

• Informational Meeting strategy with FDA Risk assessment & mitigation, incl. Significant/Non-Significant

• Risk determination

• IDE/CDx Strategy Agreement with CDRH, CBER & CDER
  
  

2 END-TO-END FDA SUBMISSION SUPPORT

• Breakthrough Device Designation application

• PMA, De-Novo & 510(k) submissions

• Submission Issue Request (SIR) preparation & response

• Investigational Device Exemption (IDE) application

• Labelling & promotional supplement management (incl. group labelling of CDx)
  
  

3 ANALYTICAL & CLINICAL VALIDATION

• Study design (accuracy, precision, interference, etc.)

• Designs tailored for the least number of clinical samples

• Data analysis, interpretation, and study reports/summaries

• Expertise in genetic tests, AAV assays, and pharmacogenomics
  
  

4 SOFTWARE & CYBERSECURITY VALIDATION

• Software validation strategy and execution framework

• Cybersecurity risk assessment and threat mitigation

• Third-party cybersecurity testing plans & compliant reports
  
  

5 SPECIALIZED QMS & POST-MARKET SURVEILLANCE

• Feasibility testing, assay development, and transfer to operations

• Risk analysis focused on false negative / false positive mitigation

• PMS strategy, adverse event reporting, and vigilance loops