Ongoing 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