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    Best Practices for Preparing for a Technical File for CE Mark

    View: 214

    Website https://compliance2go.com/product/?pid=CP2014-356 | Want to Edit it Edit Freely

    Category Medical Device

    Deadline: October 21, 2014 | Date: October 21, 2014

    Venue/Country: Online, U.S.A

    Updated: 2014-10-02 15:46:00 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    This webinar is intended to help you get familiar with how to prepare for a technical file and submit it to a notified body for CE marking purposes under directives governing medical devices: medical devices including in vitro diagnostic and active implantable medical devices. This webinar is further intended to provide guidance on the regulatory requirements set out in the applicable Directives, which help assure that medical devices are safe and effective for their intended use.

    Understanding the EU regulatory and quality requirements can significantly contribute to meeting the requirements and achieving compliance fast, resulting in saving significant amount of time and efforts and bringing innovative medical products to the EU market faster.

    This webinar will discuss EU directives and contents and format for a technical file. At the end of the webinar, you will have a great opportunity to improve your way of preparing for and managing your technical file for CE mark purposes.

    Why should you attend :

    This webinar is intended to help you get familiar with how to put together a technical file for CE mark in the European Union (EU) in accordance with three directives governing medical devices including in vitro diagnostic and active implantable medical devices.

    Areas Covered in the Session:

    How EU laws are made

    Overview of EU Directives

    Medical Device Directive (MDD)

    Active Implantable Medical Device Directive (AIMDD)

    In Vitro Diagnostic Device Directive (IVDD

    2007/47/EC Amending MDD and AIMDD

    CE Marking Principles

    Device Classification

    Contents and Format for a Technical File And Design Dossier

    Content of Declaration of Conformity

    Clinical Evaluation

    Overview of ISO 13485, ISO 14155, And ISO 14971

    GHTF/IMDRF and MEDDEV Guidance Documents

    PASS-IT Recommendations/Suggestions

    Who will benefit: (Titles)

    CEOs

    VPs

    Compliance officers

    Attorneys

    Clinical affairs (associates, specialists, managers, directors or VPs)

    Regulatory affairs (associates, specialists, managers, directors or VPs)

    Quality assurance (associates, specialists, managers, directors or VPs)

    R&D (engineers, scientists, managers, directors or VPs)

    CROs

    Consultants

    Contractors/subcontractors

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    PDF print only copy of PowerPoint slides

    60 Minutes Live Presentation

    Certificate of Attendance


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.