Device Directive Web-based Seminars
Device Directive Training Provider? - Tell us about your Training!
 online course |
 instructor-led class |
 learn at home |
 group study |
 self-directed study |
 cd-based training |
 DVD video training |
 printed book |
 e-book digital book |
 workshop seminar |
 train the trainer |
 computer-based learning |
 discount pricing |
 online tutorial |
From GlobalCompliancePanel
Construct and Manage the Technical File and Design Dossier - Webinar GlobalCompliancePanel
Overview: This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background. The Technical File is a comprehensive collection of information and documents that details
more...
Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine
Overview: The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF).
Tuesday, February 14, 2012
10: 00 AM PST | 01: 00 PM EST
more...
Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine
...vement with documentation.
The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define,
more...
Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel
... to ISO 13485: 2003. To apply a CE mark under the Medical Device Directive, 93/ 42/ EEC, certification to ISO 13485 is required in most cases. This presentation is an in-depth analysis of ISO 13485 with comparisons to ISAO 9001.
Areas Covered in the Session:
* Principles of ISO 13485: 2003
* ISO 9001 & ISO 13485 Differences
* Risk Management & ISO 14971
* FDA's MDR's &
more...
Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine
...Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF).
Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the different records. Are you
more...
Construct and Manage the Technical File and Design Dossier - Webinar By GlobalCompliancePanel
...rticipants and customers have a prior CE Mark and Medical Device Directive background.
The Technical File is a comprehensive collection of information and documents that details everything about your medical device. Understanding how to assemble this information and present the information properly is essential. If you manufacture a Class I device, a less complex CE Marking Technical File
more...
New Requirements for the Medical Device Directive MDD
... webinar on the topic of New Requirements for the Medical Device Directive (MDD)
Webinar will be on March 11, 2010. Webinar will be presented by Albert Cefalo. Mr. Cefalo has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University. For the last 21 years he has been employed by Analogic Corporation. During his career at Analogic he has involved in
more...
