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Provided by: BSI America Overview of CE Marking - 2 HoursMedical |
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Training
Provided by BSI America
Wednesday August 19, 2009, 1: 00 pm to 3: 00 pm ET
Provides a broad understanding of the requirements of the Medical Device Directive and the CE Marking approach. Participants learn the basic and initial steps an organization needs to take to sell their medical devices in the European market by gaining an overview of how the Directives are structured.
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Overview of CE Marking - 2 Hours
Wednesday August 19, 2009, 1: 00 pm to 3: 00 pm ET
Provides a broad understanding of the requirements of the Medical Device Directive and the CE Marking approach. Participants learn the basic and initial steps an organization needs to take to sell their medical devices in the European market by gaining an overview of how the Directives are structured.
Participants will also understand the different medical device classifications, how they impact the risk assessment process, and how they affect an organization s approach to obtaining CE Marking. This webinar will be a great first step for an organization that wishes to bring their medical devices to the European market effectively the first time or requires a refresher on the entire CE Marking process.
Learning objectives
* Understand the Purpose and Concepts of European Directives
* Gain an Overview of the Requirements for CE Marking
* Understand the Rules for Classification
* Review the Routes to Conformity
* Understand How Risk Management Is Related to the Medical Device Directive
* Summarize How to Get Medical Devices to Market in the EU
Who should attend
* Quality managers in the medical device industry
* Regulatory and quality staff responsible for preparing or hosting CE Marking audits
* Organizations new to the EU market with medical devices
* Those who need an understanding of the New European CE Marking approach for medical devices
* Personnel performing design and risk analysis for medical devices under development
* Companies preparing own brand or private labeling devices
Prerequisite
Students should have a basic understanding of medical device manufacturing before taking this course.
Course logistics
A webinar is an interactive multimedia presentation that allows participants to hear the instructor through a telephone conference call while following the visual presentation through a webbased interface. The web element offers the ability to ask questions via a messaging tool and allows instant polls on topics discussed in the webinar. Access information is provided at registration. An internet connection with at least Microsoft Internet Explorer 6 and the ability to make a phone call while on the internet are required.
Digital certificates of attendance are provided at the conclusion of the course.
No refunds will be provided.
Provides a broad understanding of the requirements of the Medical Device Directive and the CE Marking approach. Participants learn the basic and initial steps an organization needs to take to sell their medical devices in the European market by gaining an overview of how the Directives are structured.
Participants will also understand the different medical device classifications, how they impact the risk assessment process, and how they affect an organization s approach to obtaining CE Marking. This webinar will be a great first step for an organization that wishes to bring their medical devices to the European market effectively the first time or requires a refresher on the entire CE Marking process.
Learning objectives
* Understand the Purpose and Concepts of European Directives
* Gain an Overview of the Requirements for CE Marking
* Understand the Rules for Classification
* Review the Routes to Conformity
* Understand How Risk Management Is Related to the Medical Device Directive
* Summarize How to Get Medical Devices to Market in the EU
Who should attend
* Quality managers in the medical device industry
* Regulatory and quality staff responsible for preparing or hosting CE Marking audits
* Organizations new to the EU market with medical devices
* Those who need an understanding of the New European CE Marking approach for medical devices
* Personnel performing design and risk analysis for medical devices under development
* Companies preparing own brand or private labeling devices
Prerequisite
Students should have a basic understanding of medical device manufacturing before taking this course.
Course logistics
A webinar is an interactive multimedia presentation that allows participants to hear the instructor through a telephone conference call while following the visual presentation through a webbased interface. The web element offers the ability to ask questions via a messaging tool and allows instant polls on topics discussed in the webinar. Access information is provided at registration. An internet connection with at least Microsoft Internet Explorer 6 and the ability to make a phone call while on the internet are required.
Digital certificates of attendance are provided at the conclusion of the course.
No refunds will be provided.
About The Training Provider: BSI America
BSI America - BSI Training is one of the world's leading providers of training, information and knowledge on standards, management systems, business improvement and the achievement of regulatory approval for products.
We lead the world in advocating, defining and implementing best practice across every field of human endeavour, from business continuity to food safety.
Since its foundation in 1901, BSI...
