Join David Lim in this 60-minute session to get familiar with the European Union (EU) Directives governing medical devices including in vitro diagnostic and active implantable medical devices.
This presentation is further intended to provide practical, actionable, and sustainable guidance on the regulatory requirements set out in the three directives (MDD, IV(M)DD, and AIMDD).
Understanding and accurate interpretation of the EU regulatory and quality requirements can significantly contribute to meeting the requirements and achieving compliance fast, leading to saving an enormous amount of your time, efforts and resources and resulting in bringing innovative medical products to the EU market faster.
This presentation will offer you great insights into three directives (MDD, IVDD and AIMDD) and regulatory requirements including post-market requirements and compliance. At the end of the presentation, you will get familiarized with the applicable EU directives governing medical devices including in vitro diagnostic and active implantable medical devices, helping you implement regulatory requirements smooth and fast.
Who should attend?
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.