Clinical and Regulatory Consulting Services for the Medical Industry

iStock 000002566281XSmallOngoing professional development is essential to maintaining a knowledgeable and sustainable R&D and medical technology workforce.

Dr. Malca Chen-Zion offers a series of training sessions on a variety of subjects pertaining to the regulation of medical devices in the US and Europe. These sessions, conducted at the manufacturer's facilities, are tailored to suit your specific needs and personnel characteristics.

The training sessions include the following topics:

  • Regulatory Strategies in the Medical Device Development Process
  • Overview of Medical Device Requirements in the US and Europe
  • Basics of Good Clinical Practice (GCP)
  • Risk Management
  • Post-Marketing Requirements
  • Managing and Monitoring Clinical Trials

Malca Chen-Zion, Ph.D.

malcaDr. Chen-Zion has over two decades of experience in the fields of regulatory affairs, preclinical research and clinical trials of medical devices and biotechnology. Dr. Chen-Zion holds a Ph.D. in Biology with highest distinction from Bar-Ilan University.

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Contact Details

793 Nachal Kisufim
      Makkabbim 7179901 Israel