How to Meet All Clinical Evaluation Requirements in the Future
Is your clinical evaluation still up to date? Can you continue to use your equivalent product? Today, clinical evaluations must meet more requirements than ever before. Both MEDDEV 2.7/1 Rev. 4 and the MDCG documents provide helpful guidance on the content and preparation of a clinical evaluation report. However, the Medical Devices Regulation in particular imposes many stricter requirements for the use of clinical data.
Learn about the entire clinical evaluation process. Many practical tips will help you successfully apply the knowledge you’ve gained within your company.
- Content
- Regulatory requirements under the MDR, MDCG guidelines, and MEDDEV 2.7/1 Rev. 4
- Implementation of requirements throughout the product lifecycle
- Structure and organization of the clinical evaluation
- Interfaces with technical documentation
- Clinical and preclinical data
- Clinical evaluation report
- The clinical evaluation during an audit: How to avoid issues with the Notified Body
- Your Benefits
- You will understand regulatory requirements and be able to implement them effectively within your organization.
- You will learn about the framework and structure of a clinical assessment.
- You will discover where to find the right clinical data for your clinical assessment.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Clinical Affairs Managers
- Quality Assurance Professionals
- Regulatory Affairs Managers
- Project Managers
