Construct and Manage the Technical File and Design Dossier

June 25, 2013 - PRLog -- Description :

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).

A brief summary of manufacturing processes (flow chart including inspection and preventive monitoring steps) and validation of sterilization processes should be included in the design dossier. Be prepared to review all elements that comprise these documents and address recommended best practices.

To read more visit us at:
https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1017

Areas Covered in the Session :

> 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 Profile:
David R. Dills, an independent Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the life sciences and FDA regulated industry, has an extensive regulatory background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory landscape. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses EU regulatory requirements regarding MDD and CE Mark.