home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Courses and Workshops  
 

Medical Device Classification - Webinar by GlobalCompliancePanel

 
  September 22, 2010  
     
 


GlobalCompliancePanel, Online Training Webinar
2010-10-26


The risk class of the device determines the available conformity paths the manufacturer may use to affix the CE mark. This webinar explains the risk classification and conformity paths using the MDD version in effect after March 2010.

The Canadian Medical Device Regulations (CMDR) classifies devices into four risk categories (I, II, III, and IV). Classification follows a rule based system set forth in Schedule 1 of the CMDR.

The Global Harmonization Task Force (GHTF) has a guidance document on medical device risk classification that uses four classes (A, B, C, and D) based on risk level. This is a rule based system defined in the guidance document.

Why you should attend:Medical device classification is an important topic for device manufacturers. Many manufacturers market essentially the same device in multiple geographic markets. The classification rules for these markets may differ. The classifications are based on risk and, as a result, may lead to differing regulatory methods to demonstrate conformity.

The various systems can cause confusion, since many of the terms are the same, but the meaning is different in different regulatory systems. The GHTF guidance document is intended for adoption by regulatory agencies and by nations with developing regulatory programs. It will form the basis for new regulatory systems.

Understanding the various device classification systems, both similarity and differences, can help your company implement a more effective global marketing approach.

Areas Covered in the Session:

  • The Concepts Of Medical Device Risk
    • Factors that may impact risk
    • Regulatory controls keyed to risk
  • Classification in the US
    • Device Class
    • Device Panel
    • Device type regulation
    • Controls
      • General Controls
      • Special Controls
      • Pre-market Approval
    • FDA Guidance documents
    • Recognized consensus standards
  • Classification in the EU (MDD)
    • Rule based system in MDD Annex IX
    • Changes after March 2010
    • Device class and the EU modules
    • MDD Essential Requirements (Annex I)
    • Harmonized standards
  • Classification in Canada
    • Rule based system in CMDR Schedule 1
    • Specific requirements by device class
  • GHTF Guidance
    • Rule based system in the classification guidance
    • Linkage to the Conformity Assessment guidance

Who Will Benefit: This seminar is designed for people involved in the classification, design, development production, and marketing of medical devices.

  • Quality Managers
  • Quality Professionals
  • Regulatory Professionals
  • Marketing Managers
  • Marketing Professionals
  • Sales Managers
  • Sales Professionals
  • Risk Managers
  • R&D Managers
  • Design Engineers
  • R&D Project Managers
 
 
Organized by: GlobalCompliancePanel
Invited Speakers: Dan OLeary: - Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
 
Deadline for Abstracts: 2010-10-25
 
Registration:

Live live online training only for one participant Price: $245.00

Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care) Price: $995.00

E-mail: webinars@GlobalCompliancePanel.com
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.