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FDA - Regulatory Strategic Planning

  • Intended use and indications for use strategy- stepwise approach to facilitate time to market

  • Product classification & product code/s

  • Predicate devices

  • Applicable performance, safety, EMC and labeling standards & guidelines

  • Clinical/ Preclinical requirements to support the claims

  • Regulatory assessment of product changes (LTF/ 510k)

FDA- Preparation & Submission of Regulatory Binder

  • FDA Pre-Sub, Pre-market Notification- 510(k), De Novo, Pre IDE, IDE submission 

  • Interactive work and face to face meetings with FDA  

  • Establishment Registration & Device Listing

  • Product Labeling