Regulatory

Regulatory Affairs:

• Medical Devices and IVD Registration Services in: The United States (FDA), European Union including Transition to MDR and IVDR
• Registration Services in countries such as: Israel (AMAR), China, Canada, South America, East Europe and additional countries worldwide
• Preparing and implementing regulatory strategy, Clinical Evaluation and Biological Evaluation
• Regulatory Requirements (GSPR: General Safety and Performance Requirements)
• Compiling technical file and documentation
• Risk Management (plan, analysis and report)
• Usability (plan and activity)
• V&V planning and documentation including validations protocols for: sterilization (Gamma Irradiation and ETO)
• Shelf life, transportation, biocompatibility, cleaning and disinfection

Implementation of regulatory requirements to DHF (Device History File) and TF (Technical File)