Regulatory and Quality Solutions, LLC http://raqasolutions.com Accelerating Success for Medical Device Companies Thu, 23 May 2013 17:13:51 +0000 en-US hourly 1 http://wordpress.org/?v=3.5.1 Complaint Handling Solutions http://raqasolutions.com/2013/05/complaint-handling-solutions/ http://raqasolutions.com/2013/05/complaint-handling-solutions/#comments Thu, 23 May 2013 17:13:51 +0000 SHall http://raqasolutions.com/?p=3120 In my last post “Who’s watching your MedWatching”, I commented on some of the common issues manufacturers have with their MDR and complaint handling systems. It’s useful to know what people are doing wrong, but I think it is equally …

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]]> http://raqasolutions.com/2013/05/complaint-handling-solutions/feed/ 0 Medical Cybercrime http://raqasolutions.com/2013/05/medical-cybercrime/ http://raqasolutions.com/2013/05/medical-cybercrime/#comments Thu, 23 May 2013 15:11:58 +0000 KBerger http://raqasolutions.com/?p=3112 I saw an episode of Elementary a couple weeks ago in which a hired assassin killed someone by hacking into his pacemaker and cranking up the voltage to cause a heart attack.  Initially I thought maybe crime shows were just …

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]]> http://raqasolutions.com/2013/05/medical-cybercrime/feed/ 0 Internal Audits, the After-Thought of a Quality System http://raqasolutions.com/2013/05/internal-audits-the-after-thought-of-a-quality-system/ http://raqasolutions.com/2013/05/internal-audits-the-after-thought-of-a-quality-system/#comments Thu, 23 May 2013 13:09:28 +0000 MBurger http://raqasolutions.com/?p=3107 Why is it that Internal Audits are forgotten, or even worse feared?  Why is it so many organizations of today place so much focus on the creation of Quality Procedures, Work Instructions, Forms, etc. but do not place the same …

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]]> http://raqasolutions.com/2013/05/internal-audits-the-after-thought-of-a-quality-system/feed/ 0 Using AGILE in Medical Device Software Development http://raqasolutions.com/2013/05/using-agile-in-medical-device-software-development/ http://raqasolutions.com/2013/05/using-agile-in-medical-device-software-development/#comments Fri, 17 May 2013 15:11:26 +0000 JWalker http://raqasolutions.com/?p=3095 In school I was always taught that the medical device development process followed the waterfall model. However since entering the work force I have started to see other methods of development for different types of devices. I have recently been …

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]]> http://raqasolutions.com/2013/05/using-agile-in-medical-device-software-development/feed/ 0 MedCon 2013 http://raqasolutions.com/2013/05/medcon-2013/ http://raqasolutions.com/2013/05/medcon-2013/#comments Thu, 16 May 2013 19:15:05 +0000 RSpelich http://raqasolutions.com/?p=3091 At the beginning of this month, MedCon 2013 was hosted in Cincinnati, OH by Xavier University. The three day conference was held Wednesday May 1st, 2013 through Friday May 3rd, 2013. A wide array of topics was featured in this …

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]]> http://raqasolutions.com/2013/05/medcon-2013/feed/ 0 Why RQS Cares – Congenital Heart Walk http://raqasolutions.com/2013/05/why-rqs-cares-congenital-heart-walk/ http://raqasolutions.com/2013/05/why-rqs-cares-congenital-heart-walk/#comments Mon, 13 May 2013 14:10:04 +0000 RKasun http://raqasolutions.com/?p=3040 Today we feature a post from Deb Gimbel on why RQS Cares has chosen to support the Congenital Heart Walk. Seven years ago, my niece Riley was born with a congenital heart defect known as complete heart block, which is …

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]]> http://raqasolutions.com/2013/05/why-rqs-cares-congenital-heart-walk/feed/ 0 Localization Issues http://raqasolutions.com/2013/05/localization-issues/ http://raqasolutions.com/2013/05/localization-issues/#comments Thu, 09 May 2013 15:11:47 +0000 DBrown http://raqasolutions.com/?p=3087 Last month Serbia changed its localization so that The Instructions for Use and labeling of medical devices must be written in the Serbian language.  There was no grace period for this change, it was effective immediately. Conversely, Korea has also …

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]]> http://raqasolutions.com/2013/05/localization-issues/feed/ 0 Training, a Test of Endurance http://raqasolutions.com/2013/05/training-a-test-of-endurance/ http://raqasolutions.com/2013/05/training-a-test-of-endurance/#comments Wed, 08 May 2013 14:10:46 +0000 RKasun http://raqasolutions.com/?p=3077 I was blessed enough this weekend to run the Pittsburgh Half-Marathon with my wife, her dad, and her cousin.  I had such a blast running in my favorite city in gorgeous weather with 30,000 other crazy people! To add to …

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]]> http://raqasolutions.com/2013/05/training-a-test-of-endurance/feed/ 0 Why RQS Cares – The Race for the Place http://raqasolutions.com/2013/05/why-rqs-cares-the-race-for-the-place/ http://raqasolutions.com/2013/05/why-rqs-cares-the-race-for-the-place/#comments Mon, 06 May 2013 14:10:49 +0000 RKasun http://raqasolutions.com/?p=3041   Today we feature a post from Steve Keverline on why RQS Cares has chosen to support The Race for The Place. My father, sister and I stood in the hospital room by my mother’s side. We were anxious to …

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]]> http://raqasolutions.com/2013/05/why-rqs-cares-the-race-for-the-place/feed/ 0 When Will Academia Catch-up to the Needs of the Medical Device Industry? http://raqasolutions.com/2013/05/when-will-academia-catch-up-to-the-needs-of-the-medical-device-industry/ http://raqasolutions.com/2013/05/when-will-academia-catch-up-to-the-needs-of-the-medical-device-industry/#comments Fri, 03 May 2013 17:13:01 +0000 MBurger http://raqasolutions.com/?p=3054 This past weekend I had a really great discussion with some neighborhood friends that really didn’t know much of my background (where had I grown up, gone to school, etc.) and the question came up “what did you study in …

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