Medical Device Design Control: Get your Best Products to Market

Course Description:

The Webinar will discuss strategies for efficiently meeting the Design Control requirements as described in 21 CFR §820.30 to get your best products to market.

Course Objective:

Design Control is a critical area in marketing medical devices.  Having appropriate and effective Design Control processes in place can help one reach the market more quickly, avoid certain regulatory pitfalls, and meet the needs of your customers.


Course Outline:

  • Describe the primary benefits of implementing and maintaining effective Design Controls.
  • Review the requirements of Design Control.
  • Introduce a methodology for evaluating existing Design Control processes.
  • Outline implementation of an effective Design Control process.
  • Elements of an effective Design Control process.

Target Audience:

QA managers or project managers, Regulatory managers or project managers, or Product Development managers or project managers.
Learning Objectives:
Upon completion of this session, attendees will understand key benefits to implementing and maintaining an effective Design Control process as well as the associated regulatory requirements.  Attendees will also gain a basis for evaluation of existing Design Control processes and implementation of improvements or new processes.

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