This 1-day course is focused on the regulatory environment specific for medical device investigations and compliance with the GCP regulations applicable to these trials. An overview of when clinical trials are necessary for medical devices within European regulatory environments will be provided.

The ISO 14155 Parts 1 and 2 will be reviewed as well as the complementary national requirements throughout Europe. An explanation of how to develop a clinical strategy appropriate for a particular product and tailored to the company's overall strategy using practical examples, will be given.

Who should attend:
Clinical Research Managers and Monitors who are responsible for the setup and management of clinical investigations for the medical device industry. Regulatory and Quality Assurance specialists who want to know more about the clinical investigation approach specific for medical devices
will find this seminar beneficial.

Program:
ISO 14155 - Parts 1 and 2
• An update on ISO 14155
• How to implement ISO 14155 into the quality system
• Differences with other GCP regulations

National requirements throughout Europe
• Country by country overview
• Directive 2001/20 - Influence on device trials in the different member states

Clinical Development Plan for Medical Devices
• A global strategy

Vigilance Requirements During Clinical Investigations
Data Protection During Clinical Investigations

Discussion will take place throughout the day


For information on booking D-TARGET training courses, please contact us.