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This webinar is intended to help you get familiar with how to prepare for a technical file (or design dossier) and submit it to a notified body for CE marking purposes under directives governing medical devices: medical devices including in vitro diagnostic and active implantable medical devices. This webinar is further intended to provide guidance on the regulatory requirements set out in the applicable Directives, which help assure that medical devices are safe and effective for their intended use.
Understanding the EU regulatory and quality requirements can significantly contribute to meeting the requirements and achieving compliance fast, resulting in saving significant amount of time and efforts and bringing innovative medical products to the EU market faster. This webinar will discuss EU directives and contents and format for a technical file. At the end of the webinar, you will have a great opportunity to improve your way of preparing for and managing your technical file for CE mark purposes (both current and near future with new medical device regulation).
Areas To Be Covered :How EU laws are made
- Overview of EU Directives
- Medical Device Directive (MDD)
- Active Implantable Medical Device Directive (AIMDD)
- In Vitro Diagnostic Device Directive (IVDD
- 2007/47/EC Amending MDD and AIMDD
Overview of New Medical Device Regulation:
- CE Marking Principles
- Device Classification
- Contents and Format for a Technical File And Design Dossier
- Content of Declaration of Conformity
- Clinical Evaluation
- Overview of ISO 13485, ISO 14155, And ISO 14971
- Guidance Documents
- PASS-IT Recommendations/Suggestions
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.