Clinical studies are an integral part of the approval process for medical devices. While some devices may be approved with little or no clinical data, for others, manufacturers need to demonstrate, with safety and effectiveness data in the target population, that the product is safe for human use.
This course offers an overview of the regulatory process for medical device applications, including medical device clinical trial design and implementation. Throughout, examples and case studies will help participants apply the concepts being covered.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
Who Should Attend
This two day course is designed for Medical Device professionals involved in clinical trials. It is primarily designed to benefit the following disciplines and personnel:
- Clinical Affairs
- Medical Directors
- Regulatory Affairs
- Product Development
- Project Managers
By the end of the course, participants will be able to:
- Describe the various types of medical device clinical trials
- Understand how clinical trial design impacts the marketing of a medical device
- Understand the regulatory requirements associated with medical device clinical trials
- Describe the essentials of coordinating, monitoring, and managing a clinical trial with an emphasis on complying with Good Clinical Practice
- Understand how to develop a medical device clinical trial protocol and report.