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2012 Trend:Medical Device Classification - US and the EU as per MDD, CMDR and GHTF - Webinar By GlobalCompliancePanel  

2012-05-04 23:47:56|  分类: 默认分类 |  标签: |举报 |字号 订阅

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Medical Device Classification - US and the EU as per MDD, CMDR and GHTF - Webinar By GlobalCompliancePanel

Consultant:medicaldevice@qq.com

 

Areas Covered in the Session:

* The Concepts Of Medical Device Risk
o Factors that may impact risk
o Regulatory controls keyed to risk
* Classification in the US
o Device Class
o Device Panel
o Device type regulation
o Controls
+ General Controls
+ Special Controls
+ Pre-market Approval
o FDA Guidance documents
o Recognized consensus standards

* Classification in the EU (MDD)
o Rule based system in MDD Annex IX
o Changes after March 2010
o Device class and the EU modules
o MDD Essential Requirements (Annex I)
o Harmonized standards
* Classification in Canada
o Rule based system in CMDR Schedule 1
o Specific requirements by device class
* GHTF Guidance
o Rule based system in the classification guidance
o 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

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