Edwards Lifesciences' Rainer Voelksen on Harmonisation of Software Requirements through Standards
Contributor: Helen WinsorPosted: 12/5/2012
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Rainer Voelksen, Vice-President for International Regulatory Affairs at Edwards Lifesciences, joins Pharma IQ to discuss why standards should have internationally compatible software requirements. He also touches upon the European QM approach, the GHTF project and the International Medical Device Regulator Forum in the interview. Full Article » |
The Human Factor’s Engineering Process in the Development of Medical Device Software
Contributor: Edmond IsraelskiPosted: 8/27/2010
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Full Video » |
Verification and Validation – what is their contribution to medical device software development?
Contributor: Helen WinsorPosted: 12/21/2012
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Klaus Moritzen, Process Manager for Verification and Validation at Siemens Healthcare, joins Pharma IQ to discuss the contribution of Verification and Validation to medical device software development. Full Podcast » |
Big Pharma Cannot Afford to be Lost in Translation
Contributor: Cristina FalcãoPosted: 2/16/2012
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Since more and more clinical research and drug manufacturing are being done in multiple countries and in multiple languages, quality language services can help bring a drug to market faster, and can help streamline the clinical trial process. Translation may be required at many stages, including clinical research, regulatory submission and review, production and marketing. Full Column » |
Agile Technologies in Healthcare: Industry Overview
Posted: 8/7/2012 |
Pharma IQ in conjunction with the Agile Technologies in Healthcare Summit prepared this Agile Info Pack, the definitive resource for professionals in the agile area. The guide summarizes the key issues related to new agile development in healthcare, changes in clinical evaluations for medical devices and tips on the agile techniques for a project and address the regulatory challenges of developing a medical device. Full Whitepaper » |
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Is it possible with a MEG (Magnetoencephalography) to measure the neural activitu or the VLPO (neuron firings)? |
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what is the requirement of chewable tablet bioequivalance study for brazil and what are the general |
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what is the requirement of chewable tablet bioequivalance study for brazil and what are the general |
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