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  • Construct and Manage the Technical File and Design Dossier

Product Id IQW15C9041
Speaker David Dills
Duration 60 Mins
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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). Once placed on the market, national Competent Authorities have the right to review EU Technical Files regardless of classification at any time

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.

An incomplete or improperly completed Technical File may result in unexpected delays or even prevent market entry. Whereas the expression “Technical File“ is usually associated with Class I, IIa and IIb, and “Design Dossier“ for class III products., the files are retained on the premises of the manufacturer or the Authorized Representative for potential review of Competent Authorities and Notified Body. Dossiers have to be submitted to the Notified Body for review prior CE-Marking of your product. It is not necessary to include all documents in the design dossier which have already been subject to an ISO/MDD type Audit by the Notified Body. Examples of documents not necessary to be included are Quality Manuals and related lower-level documents. 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. 

  • 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
  • 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

David R. Dills, Senior Consultant, Regulatory Affairs & Compliance NOVUSLIFE

currently provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 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 QS and regulatory audits.

He has been directly involved with constructing, reviewing, and/or remediating regulatory submissions, including 510(k), PMA, IDE applications, BLA and NDA submissions, preparing Supplements, Amendments, U.S. Agent for clients, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.