The DHF, DMR, DHR, and Technical File / Design Dossier - With the New ISO 13485:2016 and EU MDR Requirements

DoubleTree by Hilton Las Vegas Airport, Las Vegas, NV

Map Event Location Share this Event

Event Details

Begins: October 5, 2017

End: October 6, 2017

Event Location: DoubleTree by Hilton Las Vegas Airport, Las Vegas, NV

Website: http://www.globalc..08SEMINAR

Event Organizer

Event Organizer: Global Compliance Panel

Contact Person:

Phone Number: +1-800-447-9407

Website: https://www.globalcompliancepanel.com/

Overview

We will consider the following:

    The Design Control requirements of the CGMPs, 21 CFR 820.30
    The Design History File - documenting Product Design Control and its nine elements
    The Device Master Record and the Device History Record
    The EU's Medical Device Directive
    The "Essential Requirements"; and their documentation
    The remaining elements of a Technical File / Design Dossier
    Trends
    Two attendee projects

BECOME A STRATEGIC PARTNER

We are looking to build strategic relationships with conference and event organizers paving the way for industry advancements and education.