Construct and Manage the Technical File and Design Dossier

This CE technical files based training Webinar will discuss the difference between Technical File and Design Dossier and explain how to create them and the best practices.

Why Should You Attend:

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.

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.

Attend this Webinar to know how to prepare what elements to review, when to submit and what are the recommended best practices.

Areas Covered in the Webinar:

• 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

Instructor 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. Mr. Dills 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 and counsel on regulatory and compliance requirements, prepares/reviews worldwide submissions/dossiers/technical files, provides direction and regulatory plan for global product registrations, and addresses EU and requirements regarding MDD and CE Mark, among other regulatory aspects to support product commercialization and regulatory plan strategies. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies and demonstrates credible experience to maximize business performance in the devices arena. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones.