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Confidentiality in Medical Device Manufacturing

admin — Sat, 04 Feb 2012 03:20:07 +0000

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Confidentiality in Medical Device Manufacturing

Prescription for medical expansion

admin — Thu, 02 Feb 2012 21:53:23 +0000

Cutting Tool Engineering Editor Alan Richter discusses the recent expansion of Dynomax Inc., headquartered in Wheeling, Ill. The company, which is targeting the medical device market for growth, has added two new facilities in the past two years. The company’s headquarters in Wheeling, Ill., and the new Lincolnshire, Ill., facility gives Dynomax four locations throughout the Northwest suburbs of Chicago.

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Prescription for medical expansion

Medical Device Animation – Short Demo

admin — Wed, 01 Feb 2012 17:13:40 +0000

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

The Compliance View-Set in Integrity for Medical Devices – PTC

admin — Mon, 30 Jan 2012 13:29:14 +0000

To view the full length on-demand webinar, please click here: gurl.im In this excerpt from the Automating Risk Management webinar, PTC’s Steve Mostello demonstrates how a compliance specialist can easily navigate through development artifacts in Integrity.

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The Compliance View-Set in Integrity for Medical Devices – PTC

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

admin — Mon, 30 Jan 2012 01:02:24 +0000

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

Medical Device Supplier Controls & Quality Management Conference 2012

admin — Fri, 27 Jan 2012 20:23:46 +0000

Medical Device Summit’s Supplier Controls & Quality Management Conference left attendees shaking their head in awe with the quality and volume of critical content presented by industry speakers. When Kim Trautman speaks along side Medtronic, Abbot, J&J, Edwards Life Science, BD and others there is a lot to be learned. The take-aways for the attendees were huge. Sponsors capitalized on the in conference interaction between and among attendees and speakers to learn about specific pain points in supplier controls and conducted many one on one meetings.

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Medical Device Supplier Controls & Quality Management Conference 2012

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

admin — Fri, 27 Jan 2012 16:22:32 +0000

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

Kim Trautman at Supplier Controls & Quality Management Conference

admin — Thu, 26 Jan 2012 21:05:17 +0000

Kim

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Kim Trautman at Supplier Controls & Quality Management Conference

Electronic Tattoo Monitors Brain, Heart and Muscles

admin — Thu, 26 Jan 2012 18:37:38 +0000

John Rogers and his team at the University of Illinois, Champaign-Urbana have come up with a way to monitor the body electronically that really sticks. They have developed a small, flexible circuit device that sticks comfortably to the skin and is artfully camouflaged as a temporary tattoo. It can read a patient’s brainwaves, heart rate and muscle activity while they are going about their normal activity, making it possible to cut back on visits to the doctor’s office. Rogers envisions one day an implantable circuit that diagnoses and perhaps treats seizures.

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Electronic Tattoo Monitors Brain, Heart and Muscles

Overview of the 510(k) medical device clearance process in the USA

admin — Wed, 25 Jan 2012 18:09:05 +0000

Considerations when preparing and submitting a medical device 510(k) application to the US Food and Drug Administration (FDA).

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Overview of the 510(k) medical device clearance process in the USA