Archive for medical-devices

Medical Device Animation – Short Demo

Medical device samples from our animation studio including – Gamma Knife, Vascular Stent, CyberKnife, Stomach Stapling, Diabetes Pump, Bone Implant, Alpha Stim and ArmPort. See more at www.schoncreative.com

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Medical Device Animation – Short Demo

Medical Device Summit – Supplier Controls & Quality Management Conference Panel Discussion Part I

This 10 minute video is part I of a series of videos from a panel discussion from Medical Device Summit’s Supplier Controls & Quality Management Conference. Steve Niedleman, Moderator and Lead Quality System & Compliance Consultant leads a discussion on “Challenges in Change Control Requirements”. Rita Guzzetta of Medtronic address the importance of documentation even at what is perceived to be “low level changes. Mike Buffington of GE talks about what you must declare as a change and that you must also provide the vehicle enabling change communication. Joel Roth of Edwards Lifescience references how a Chinese sister company of one of their suppliers made a design change without notifying Edwards Lifescience and the consequence of that change. Finally a question from the audience focused on a centralized process system to assure that change notification works across suppliers with various divisions

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Medical Device Summit – Supplier Controls & Quality Management Conference Panel Discussion Part I

Kim Trautman at Medical Device Summit’s Suppler Controls & Quality Management Conference

In this 5-minute video, Kim Trautman, FDA’s Medical Device International Quality Systems Expert, speaks with Sangita Viswanathan, Editor-in-Chief, Medical Device Summit, on managing internal suppliers; benchmarking; and tackling global supply chain challenges. Trautman, who has been recently named FDA’s Acting Associate Director-International Affairs asks the device sector to: 1. Pay attention to internal suppliers; “a supplier is a supplier even if they are part of the same corporate structure, and you still need soundproof terms of agreement under QSR;” 2. Look at some best practices followed by automotive, telecommunications and aerospace sectors for risk management and supplier controls, and adapt these for consistent, better quality results; and 3. Work with FDA which has number of initiatives for managing global supply chain integrity and quality, and have the assurances in place to understand your supplier, manage risk and ensure a good quality product.

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Kim Trautman at Medical Device Summit’s Suppler Controls & Quality Management Conference

Tornier Announces 2011 Fourth Quarter and Full Year Conference Call

AMSTERDAM–(BUSINESS WIRE)–Tornier, N.V. (NASDAQ: TRNX), a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, announced today that it will report financial results for the three months and full year ended December 31, 2011, after the market close on Thursday, February 23, 2012. The Company also announced that Doug Kohrs, President and Chief Executive Officer, and Carmen Diersen, Chief Financial Officer, will host an investor conference ca

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Tornier Announces 2011 Fourth Quarter and Full Year Conference Call

The Ins And Outs Of The Aesthetics Market: An Interview With Steven H. Dayan, MD

The effectiveness of a product is only one aspect of how well a device will succeed in the aesthetics market. In the following interview, Steven H. Dayan, MD, a noted Chicago plastic surgeon, tells Medtech Insight that manufacturers seeking to enter this space need to spend time on market research and fully understand where their products will be used and who will use them.

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The Ins And Outs Of The Aesthetics Market: An Interview With Steven H. Dayan, MD