Resources
Within this section, you will find a wealth of operationally important information. We have generated this section as clinical and regulatory professionals for clinical and regulatory professionals. Based upon some two decades of therapeutic and diagnostic product development experience, we believe the content and presentation of the topics within this section will serve as a valuable orientation for our clients and potential clients. This section contains information on:
- Competent Authorities : Contact and weblink information for senior management, vigilance and clinical study staff.
- Notified Bodies: A database to identify those Notified Bodies accredited to provide Conformity Assessment services for your specific medical device.
- European Standards: A database to identify which European Standards apply to your specific medical device.
- Clinical Research Centers: A working tool to identify major clinical research sites throughout Europe.
- Ethics Committees: A working tool addressing the regulatory basis for ECs and a comprehensive list of ECs in each country in Europe.
- Regulations: A differentiated analysis of medical device, advanced therapies and pharmaceutical regulatory issues in the european Directives.