Since this is my first contribution, let me give you the intro – my name is Mike Andreas and I am a Senior Quality Engineer with RQS. My background, aside from 5 years in the medical imaging industry, includes mechanical …
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RQS in the News – Cleveland Office Opening
Posted 440 days ago byRegulatory and Quality Solutions is in the news again, this time featured in the Pittsburgh Business Times. The article describes the Cleveland market and why it is an attractive location for the first branch office of RQS. The article can …
Posted in Announcements, News
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FDA ISO 13485:2003 Pilot Program
Posted 440 days ago byEffective June 5, 2012, FDA will begin a voluntary pilot program to accept voluntary submissions of external audit reports compiled by one of the founding members of the Global Harmonization Task Force (GHTF). Said audit reports will be reviewed by …
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BSI is hosting a webinar on April 24th, 2012 at 11:00 AM on the 7 common mistakes of medical device startups. I would anticipate that their information stems from their work as a notified body for manufacturers seeking market clearance …
Posted in Announcements, News
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Kim Platt joins RQS as Principal Specialist
Posted 511 days ago byGood evening everyone, Please join me in welcoming team member Kim Platt, Principal Specialist, to RQS! Kim comes to RQS with an impressive background in several areas including compliance, applications, and healthcare. Kim attended Robert Morris College earning her Bachelor …
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Good evening everyone, Please join me in welcoming team member Lori Smith-Sakalousky to RQS! Lori earned a Bachelor of Science in Business Administration with a concentration in Psychology from Clarion University. Lori later earned a Master’s of Business Administration from …
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Mobile Medical Applications: Wellness Apps
Posted 518 days ago by
After a small hiatus, the Mobile Medical Apps blog series is back! Today we’ll take a look into wellness and weight-loss applications. The market is flooded with mobile applications focused on wellness, from circuit training (I love the Sworkit app) …
Posted in Mobile Medical Applications, News
Tagged 510(k), 60 minutes, annoyance, barcodes, bodymedia, calorie burn, electronic logs, FDA, fitness and health, gray area, iPhone, jawbone, mobile applications, mobile apps, myfitnesspal, personal data, quick scan, registration database, weight watchers, wellness products, workouts
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Mobile Medical Applications: Visual Calibration
Posted 565 days ago by
Our third installment of the mobile medical apps series finally features a mobile medical app. This app in particular, the MediCal QAWeb Mobile app, is used to calibrate the screen of an iPad for diagnosis of medical images viewed on …
Posted in Mobile Medical Applications, News
Tagged 510(k), barco, calibration, computer file, diagnosis, FDA, fda clearance, image credit, image viewing software, ipad, job, medical applications, medical device, medical images, press release, princeton, regulatory effort, regulatory pathway, software developers, submission, submissions
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Mobile Medical Applications: Cyber Security
Posted 569 days ago by
As with all software and technology, security is, and will always remain, a hot-button topic. It is even a point of contention for computer consumers – Mac vs. PC debates often will focus on how Mac’s don’t “need” virus protection …
Posted in Mobile Medical Applications, News
Tagged 510(k), FDA, iPhone, MDD, medical device, Medical Devices, mHealth, mma, Mobile Health, Mobile Medical Applications, mobile medical applications, mobile medical apps
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Mobile Medical Applications: What’s App-ening?
Posted 575 days ago byIt has been predicted by many technology pundits that smartphones will be in everyone’s hands within the next few years. Of course there will be different flavors of smartphones to adjust to different consumer ranges, but the way of the …
Posted in Mobile Medical Applications, News
Tagged Android, Apps, Blackberry, FDA, iPhone, mHealth, mma, Mobile Health, mobile medical application, mobile medical applications, smart phone
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