Boston Professional Events List


Live Webinar Construct and Manage the Technical File and Design Dossier


Date
Jun 12, 2018 - 01:00 PM - 02:00 PM
Organizer
conference Manager
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,
FL,
US,
ZIP: 33021
Phone: 347 282-5400

Ticket Price: $179 One Dial-in One Attendee | Corporate Live Recorded $279 One Dial In - Max 10 attendees |Group $695 Multiple locations upto 5 dial in | Recorded $249
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 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 may be required. In the case of Class IIa, IIb and Class III devices, a more complex CE Technical File or Design Dossier must be prepared. EU Technical File construction is subject to review by a Notified Body if the medical device is Class I with measuring or sterile function, Class IIa, IIb, and III (Design Dossier).
 

Areas Covered

 

•      Learn the differences between the Tech File and Dossier and why the construction phase is so important
•      Compile the EU Technical File or Design Dossier and ensure Format and Content expectations are addressed appropriately
•      Understand why Design Dossier is viewed as a subset of the Tech Documentation with emphasis on “design”
•      Determine exactly which materials need to be assembled
•      NB must examine the application for examination of the design dossier and, if the product conforms to the relevant provisions of the Directive, issue the application with an EC design-dossier certificate
•      Review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s)
•      Determine applicable standards and address company-specific SOPs for constructing and managing your files
•      European Norms and Standards and other documents supporting Technical Files and Design Dossiers
•      Guidance on Design-Dossier Examination and Report Content

 

Who will Benefit

 

This webinar will provide valuable assistance and guidance to medical device companies responsible for constructing and managing their Technical Files and Design Dossiers. Employees who will benefit include: 

•     All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview; however, it is assumed that customers/attendees have some prior MDD and CE Mark background as applicable
•     Regulatory Affairs/Regulatory Affairs Specialists
•     Clinical Affairs
•     Quality and Compliance
•     Marketing & Sales 
•     Distributors
•     Engineering/Technical Services
•     Consultants



Speaker Details


Speaker Profile


David R. Dills, Global Regulatory Affairs & Compliance Consultant, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts regulatory and compliance assessments. 

Event Categories
Keywords: Education




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