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 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). Once placed on the market, national Competent Authorities have the right to review EU Technical Files regardless of classification at any time.
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Webinar Takeaway
- 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
Industries who can attend
This 60 -minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
Faculty David R. Dills
David R. Dills, is currently the Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations. He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products.
