Medical device product development process

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Live Webinar Medical Device Product Development Process Date: Wed, December 3, 2014 Instructor: Karl Leinsing

Time: 10:00 AM PST | 01:00 PM EST

Duration: 60 Minutes

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Location: Online

Overview: We will give you the steps and information to develop a medical device product. The documentation discussed can also be used and is often requested by the FDA and required by many ISO procedures for controlling the design process. We will discuss why certain steps are so important in the design process and that many steps are not just wasted time and paperwork.

Areas covered in the session: How to start a development project. Patent search Putting together a comprehensive systems requirement document. 1-10-100 Rule Market research and customer needs Design in quality & manufacturability Prototype & testing Production Tooling Qualification, Validation, & Verification Trace Matrix Technical File & Regulatory Documentation

Who Will Benefit: Medical Device Design Engineers Product Managers Directors of Product Development VP of Product Development Inventors Project Leaders Technical Team Leaders

About Speaker Karl Leinsing President, ATech Designs, Inc. Karl Leinsing has experience with design and project management since 1988 and has been in the Medical Product Device Design and Development industry since 1992. His areas of expertise include full life cycle product development, product conception,

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