CE Mark Certification: Compile a CE Marking Technical File (or Design Dossier for Class III) containing evidence of compliance to the Medical Devices Directive (or the IVD/AIMD Directives) - Impact of the MDR for Europe

Date : 29th November 2018 to 29th November 2018

Place : Switzerland, Kanton Zurich

Website :https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901864SEMINAR?allconferencealerts-nov-seo

Contact Person:Event Manager

Description:

Identify and locate all regulatory requirements and guidance documentation necessary to write procedures enabling the creation and maintenance of compliant technical files and design dossiers

CE Mark Certification: Compile a CE Marking Technical File (or Design Dossier for Class III) containing evidence of compliance to the Medical Devices Directive (or the IVD/AIMD Directives) - Impact of the MDR for Europe will be held in Kanton Zurich,Switzerland on date 2018-11-29

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Deadline for abstracts/proposals : 29th November 2018

Keynote Speakers : David R. Dills Global Regulatory Affairs & Compliance Consultant and President, NovaQual David R. Dills, Global Regulatory Affairs & Compliance Consultant, Interim President, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals/supplements, cosmetics and biopharmaceutical manufacturers in multiple medical specialtie

Conference Highlights :Introductions and overview of the EU Directives Identify the EU Directives and standards applicable to your product Comply with the implementation details and requirements of the EU MDR & IVDR Design a new product, or evaluate an existing product, for conformity with these Directives and standards Conduct and document a detailed Hazard Identification and Risk Assessment of your product Complete the necessary Technical File and documentation required to meet EU legal requirements Unders

Venue :Hilton Zürich Airport, Hohenbühlstrasse 10, 8152 Opfikon, Switzerland

Check the event website for more details.