This seminar is intended to help global healthcare industry professionals get familiar with US laws and regulations governing medical devices. In particular, this seminar will discuss regulatory requirements applicable for various different types and classes of medical devices.
In this 60-min presentation, the speaker will guide you through the details of what is required to obtain US FDA approvals or clearances for medical devices.
This has been helpful for those preparing for the US Regulatory Affairs Certified (RAC) exam.
- It was perfect! It was thorough yet broad enough to encompass all of the important points on the subject matter. I liked your presentation: very nice flow and explanations! - by Regulatory Affairs Manager
- It’s a very nice spearheaded presentation, "real time saver"! - by Program Development Manager
- US Laws and Regulations Governing Medical Devices
- Medical Device Classification
- General Control and Special Control
- Medial Device Panels
- Label and Labeling
- Clinical Trial Requirements and IDE
- Quality System Regulations (cGMP)
- Postmarket Requirements
- Guidance Documents and Standards
- Practical, Actionable, and Sustainable Solutions (PASS)
- Speaker’s Recommendations for Best Practices based on Actual Cases
Dr David Lim,
President and Principal Consultant ,
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. 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 seven 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, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.