Construct and Manage the Technical File and Design Dossier

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Live Webinar on

Construct and Manage the Technical File and Design Dossier
Date & Time:

Thursday, August 11, 2011
10:00 AM PDT | 01:00 PM EDT

Register Now

Duration: 60 Minutes
Instructor: David R. Dills
Location: Online
Price : $245.00 (for one participant)

Instructor Profile:
David R. Dills
This Webinar will provide a substantive overview and outline
Industry Regulatory &
differences between the Technical File and Design Dossier for those
Compliance Consultant,
device firms dealing with the global regulatory landscape.

David R. Dills, an independent
It is assumed that participants and customers have a prior CE Mark
Regulatory & Compliance Consultant
and Medical Device Directive background. The Technical File is a
with more than 22 years of hands-on
comprehensive collection of information and documents that details
experience and a proven track
record within the FDA regulated
everything about your medical device. Understanding how to
industry, has an extensive
assemble this information and present the information properly is
regulatory and compliance
essential. If you manufacture a Class I device, a less complex CE
background with Class I/II/III and
Marking Technical File may be required. In the case of Class IIa, IIb
IVD devices and managing and
and Class III devices, a more complex CE Technical File or Design
handling activities within the global
Dossier must be prepared. EU Technical File construction is subject to
regulatory and compliance
review by a Notified Body if the medical device is Class I with
landscape. He manages quality,
measuring or sterile function, Class IIa, IIb, and III (Design Dossier).
regulatory and compliance projects
with multiple competing priorities

having a direct impact on site
Areas Covered in the Session:
operations and commercial
opportunities and develops
strategies for governmental approval
Learn the differences between the Tech File and Dossier and
to introduce new products to market,
why the construction phase is so important
provides guidance and direction on
Compile the EU Technical File or Design Dossier and ensure
regulatory and compliance
Format and Content expectations are addressed appropriately
requirements and prepares/reviews
Understand why Design Dossier is viewed as a subset of the
Tech Documentation with emphasis on "design"
submissions/dossiers/technical files
and addresses requirements in the

Determine exactly which materials need to be assembled

EU, Pacific Rim and The Americas
NB must examine the application for examination of the design
regarding all aspects of device
dossier and, if the product conforms to the relevant provisions
commercialization and especially
of the Directive, issue the application with an EC design-
FDA activities. Background
dossier certificate
encompasses broad capabilities in
Review all existing documentation in support of meeting the
quality systems, validation,
applicable Essential Requirements of the Directive(s)
regulatory affairs, GxP compliance,
auditing, interfacing with the
Determine applicable standards and address company-specific
SOPs for constructing and managing your files
regulatory agencies, managing
enforcement actions and mitigating
European Norms and Standards and other documents
compliance exposure for companies,
supporting Technical Files and Design Dossiers
working with Notified Bodies, AR's
Guidance on Design-Dossier Examination and Report Content
and demonstrates credible
experience to maximize business
Click here to register for this webinar
performance in the devices arena.
He strives to optimize business
performance through proactive
Who Will Benefit:
strategies to mitigate compliance

exposure by providing strategic and
This webinar will provide valuable assistance and guidance to
tactical solutions that facilitate the
achievement of regulatory
medical device companies responsible for constructing and managing
milestones. ...more
their Technical Files and Design Dossiers. Employees who will benefit
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All levels of management and departmental representatives
and those who desire a better understanding or a "refresh"
Your Necessity is our Priority
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
Engineering/Technical Services
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely

benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,
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