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2014 - Fundamentals of Medical Device Design Controls



VenueOnline event, USA - United States USA - United States

KeywordsFundamentals; Medical Device; Design Controls


Topics/Call fo Papers

This seminar will cover the Design Control requirements under FDA and ISO 13485. It will discuss when and how to start the design control process for a new product or significant change to a product. The basics of all areas of design controls from Planning through Product Transfer will be covered.
Course Objective:
Design controls are one of the most frequent areas sited on FDA Quality System Inspections (483 Observations). Yet quality professionals often do not get involved in the product development process until near the time of product transfer to manufacturing
Course Outline:
? FDA and ISO 13485 Design Control Requirements
? When and how should you start Design Controls
? Design Control areas
? Design and Development Planning
? Design Input
? Risk Management
? Design Output
? Design Review
? Design Verification
Target Audience:
? Quality Management
? Quality auditing
? Product development
? Research and Development
? Quality Engineering
? Production Engineering
? Clinical Affairs
? Regulatory Affairs
? Quality auditors
? Medical device Consultants
Webinar Price tags :
$ 229.00 Single Attendee
$ 749.00 Group ? Max 10 Attendees per location
$ 269.00 Access Recorded Version online
$ 399.00 Buy Training CD-DVD
For More Details or Enrollment Or Registration :
Contact : complianzworld
Phone : +1-866-978-0800
Fax : +1-888-883-7697
E-mail ID :

Last modified: 2014-08-22 04:41:39