To place a medical device on the European market, device firms are required to demonstrate conformity of the device with the relevant essential requirements for the device’s clinical safety and performance for CE marking. In particular, clinical evaluation is required to ensure that there is sufficient clinical evidence to support the device safety and performance when used as indicated throughout the lifetime of the medical device on the market. Clinical evaluation applies to all classes of medical devices.
In this seminar, the speaker will discuss recommended guidelines on how to perform and document clinical evaluation and clinical evaluation report as one of key elements of the technical documentation for CE marking purposes.
The speaker will walk you through the current recommended guidelines and practices.
Areas Covered in the Session :
- Applicable Laws
- CE Marking
- Clinical Evaluation Requirements
- Clinical Evaluation: Format and Contents
- Key Considerations
- Common Mistakes
- PASS-IT Recommendations for Best Practices: Dos and Don’ts
Who Should Attend:
- Research and Development Departments
- Quality Departments
- Regulatory Affairs Departments
- Engineering Departments
- Clinical Affairs Departments
- Compliance Officers
Course Director: DR. DAVID LIM
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.
Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.