Regulatory Affairs

iStock 000024154021 ExtraSmall (1)The pathway from product design to product launch for a new medical device is often unclear. And as devices become more complex, the challenges and questions increase.

With Dr. Chen-Zion as your partner, you will gain a clear understanding of the regulations and requirements applicable to your medical device. Dr. Chen-Zion provides know-how beyond what is available in published guidance documents.

Dr. Chen-Zion has the expertise to help your medical device meet the many challenges of the approval process, for products in the U.S., Europe, and Canada.

Regulatory services include:

Preparation and Submission of Regulatory Binder:

  • Pre-market notifications [510(k)s]
  • Pre-market approval (PMA)
  • Investigational Device Exemption (IDE) & Pre-IDE
  • Technical File
  • Develop and implement regulatory strategy
  • Post-market surveillance and clinical activity
  • Interactive work with the regulatory authorities (Israel and international)
  • Communication and meetings with FDA and other regulatory authorities.

Implementation of Regulatory Requirements in R&D:

  • Risk analysis management
  • Performance test design (protocol and summary report)
  • Biocompatibility and sterilization tests