Implementing Medical Device Directive (MDD) for CE Mark in EU

Duration: 60 Minutes
This webinar will help you understand the European Union (EU) Medical Device Directive (MDD), which governs medical devices. This webinar is further intended to provide guidance on the regulatory requirements set out in the applicable Directive, which helps to assure that medical devices are safe and effective for their intended use.
Implementing Medical Device Directive
Instructor: David Lim
Product ID: 500589
Understanding the EU regulatory and quality requirements can significantly contribute to addressing the applicable regulatory requirements and achieving speedy compliance, resulting in saving a significant amount of time and efforts and bringing innovative medical products to the EU market faster.

This webinar will discuss EU Medical Device Directive, requirements and compliance. At the end of the webinar, you will get familiarized with the applicable EU Directive governing medical devices.

Why Should you Attend:
To bring medical device products into the EU market, it is imperative for the device firms to learn about the applicable regulatory and quality requirements so that the applicable requirements can be adequately addressed in a least burdensome manner.

Objectives of the Presentation:
  • EU Laws For Medical Devices
  • CE Marking Principles
  • Overview of the European Medical Device Regulations and Regulatory Framework for Medical Devices
  • Medical Device Directive (MDD)
  • Device Classification and Rules
  • 2007/47/EC amending MDD and AIMDD
  • Essential Requirements
  • Technical File: Contents and Format
  • ISO 13485, ISO 14155, and ISO 14971
  • Clinical Evaluation and Clinical Trials
  • GHTF and MEDDEV Guidance Documents
  • Recent Trends and Future Changes
Who can Benefit:
  • Regulatory Affairs
  • Quality Professionals
  • R&D
  • Complaint And Risk Management Personnel
  • Consultants
  • Contractors/Subcontractors
  • CEOs
  • VPs
  • Clinical Affairs
  • Other Interested Parties
$375
Recorded Session for one participant
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner.

Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters.

Over the years, Dr. Lim has analyzed thousands of FDA warning letters including thousands of MDRs. Dr. Lim has also attended more than 50 FDA advisory panel Meetings and analyzed the subject matters and decision-making processes. Dr. Lim is familiar with hundreds of medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim also is a regulatory coach, mentor, consultant and public speaker for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Dr. Lim has been actively engaged in identifying and addressing regulatory hurdles and submission issues including, but not limited to, patient-safety signals and concerns. Dr. Lim co-authored the Regulatory Affairs Professional Society (RAPS)'s online class materials for EU medical device regulations.
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