Author Archives: admin

Cleveland, We Have a Problem

Posted ago by admin

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 …

RQS in the News – Cleveland Office Opening

Posted ago by admin

Regulatory 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 …

FDA ISO 13485:2003 Pilot Program

Posted ago by admin

Effective 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 …

Upcoming Webinar – Common Mistakes for Medical Device Startups

Posted ago by admin

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 …

Kim Platt joins RQS as Principal Specialist

Posted ago by admin

Good 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 …

Lori Smith-Sakalousky joins RQS as Principal Specialist

Posted ago by admin

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 …

Mobile Medical Applications: Wellness Apps

Posted ago by admin

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) …

Mobile Medical Applications: Visual Calibration

Posted ago by admin

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 …

Mobile Medical Applications: Cyber Security

Posted ago by admin

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 …

Mobile Medical Applications: What’s App-ening?

Posted ago by admin

It 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 …