Understanding Medical Device Design Controls What, Why, and How

Date : 6th May 2021 to 6th May 2021

Place : United States, East Camden

Website :https://worldcomplianceseminars.com/

Contact Person:WCs Conference

Description:

Fortunately, Alan Golden Principal at Design Quality Consultants, LLC with over 30 years’ experience working in the medical device industry will focus on introducing the attendees to the regulatory requirements stipulated under the US Medical Device Quality Systems Regulation. Each of the seven key elements of Design Control compliance will be briefly reviewed. In addition, specific GMP requirements, submission dossier preparation throughout the Design Control lifecycle and submission strategy will be discussed. This Design Control course is US-focused. The participants will gain a fundamental understanding of how medical devices are regulated in the US: the main legal basis, FFDCA (21 U.S.C. 301) and the specific Medical Device Quality Systems Regulation, and the comparison/contrast of the GMP requirements imposed on the medical devices and pharmaceutical products in the US. In addition, the partipants will be introduced to a brief overview of relevant global regulatory framework including the EU MDR 2017 and the latest ISO standards (ISO 13485:2016).

Understanding Medical Device Design Controls What, Why, and How will be held in East Camden,United States on date 2021-05-06

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Deadline for abstracts/proposals : 6th May 2021

Keynote Speakers : Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance.

Conference Highlights :Introduction My background and experience Why design control Purpose of design control Benefits of design control Overview of design control Scope and Responsibilities Devices requiring design control Scope and responsibility definitions Management responsibilities Design and Development Planning When a plan is required Elements of a plan Project management Planning tools Change of plans Design Input Design input definitions and requirements When research ends and deve

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