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Global Medical Device Regulations Seminar, US, EU, Canada, Argentina, Australia, Brazil, India, Japan, Mexico

 
  August 22, 2012  
     
 
ComplianceOnline, Hyatt Regency Minneapolis: 1300 Nicollet Mall, Minneapolis, MN 55403
2012-09-13


Course Description:

At this workshop, Dr. David Lim will walk you through to get familiar with the medical device regulations in the following twelve (12) countries.


United StatesEUCanadaArgentinaAustraliaBrazil
IndiaJapanMexicoRussiaSouth KoreaTaiwan


This workshop is intended to provide guidance on medical device classification and registration requirements in these countries.

During this workshop (1st day), medical device regulations of twelve countries will be discussed.

On the second day, we will discuss ISO 13485, ISO 14155, ISO 14971, GHTF documents, and MEDDEV guidance documents, etc. for quality and adverse event reporting including group discussions facilitating interpretation, understanding, and implementation of medical device regulations. 

Why Should You Attend:

Understanding global medical device regulations and requirement and adequate implementation of applicable medical device regulations can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment.

At this workshop, you will get familiar with medical device regulations of twelve (12) countries concerning medical devices, active implantable medical devices and in vitro diagnostic medical devices for adequate implementation and successful registration.

The following areas will be discussed during workshop:

  • Medical device regulations in US, EU, Canada, Argentina, Australia, Brazil, India, Japan, Mexico, Russia, South Korea, Taiwan
  • In EU, the following four Directives will be discussed.
    • DIRECTIVE 93/42/EEC Concerning Medical Devices (MDD)
    • DIRECTIVE 90/385/EEC Concerning Active Implantable Medical Devices (AIMDD)
    • DIRECTIVE 98/79/EC Concerning in vitro diagnostic medical devices (IVDD)
    • DIRECTIVE 2007/47/EC Amending MDD and AIMDD
  • ISO 13485
  • ISO 14155
  • ISO 14971
  • GHTF documents
  • MEDDEV guidance documents
    • Clinical investigation
    • Adverse event reporting

 

 

 
 
Organized by: ComplianceOnline
Invited Speakers:

Instructor:

Dr. David Lim
Ph.D., RAC, ASQ-CAQ

Dr. David 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, 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/davidlim), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. 

 
Deadline for Abstracts: 2012-09-13
 
Registration: http://www.complianceonline.com/ecommerce/control/seminar?product_id=80046SEM&?channel=hummolgen
E-mail: referral@complianceonline.com
 
   
 
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