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