BioMedical Strategy
REGULATORY AFFAIRS

Advice and hands-on support mainly for FDA related activities & European CE compliance strategies, accomplishes a tailor-made and efficient pathway to product development, manufacturing and marketing.

  • Regulatory Strategy:  
    • Intended use and indications for use strategy  
    • Classification & Product code/s  
    • Reference guidances and standards  
    • Survey of possible predicates [Substantial Equivalence Data]  
    • List of requirements with relation to safety, performance and efficacy  
    • Top-level work plan  
  • Preparation of the submission binder:
    • Premarket Notifications 510(k)s, Premarket Approvals (PMA)  
    • Pre-IDE & Investigational Device Exemptions (IDE`s)   
    • Postmarket Surveillance and Clinical activity  
  • Interactive work with the regulatory authorities 
  • Israeli and other international authorities

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