I’ve always had a rocky relationship with my alarm clock, specifically the snooze button. In my current clock it’s built into the base (not the display, where all the cool buttons hang out), and it’s angled, narrow and difficult to …
Category Archives: News
Everyday Usability – Alarm Clock Edition
Posted 24 days ago by
Posted in Everyday Usability, News
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New Biocompatibility Draft Guidance
Posted 30 days ago byFDA issued a new draft guidance document on biocompatibility on Tuesday April 23, entitled Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. It is intended to replace the ODE General Program Memorandum #G95-1. …
Posted in News
Tagged Biocompatibility, biological evaluation, draft guidance document, FDA, fda clearance, G95-1, Guidance Document, iso 10993, ISO 10993-1, Medical Devices, premarket submissions, standard iso
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Crash Those Symbols – FDA Proposed Rule
Posted 31 days ago by
Make some noise people – the FDA may be making labeling easier on the medical device and biological product industries by way of harmonized symbols! According to the proposed rule, dated April 15, 2013, the FDA is proposing the revision …
Posted in News
Tagged biological product, FDA, harmonized symbols, labeling, labeling products, labels, medical device, medical device labels, Medical Devices, regulators, regulatory structure, sdo, standards development organization
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Proposed Order on AEDs
Posted 32 days ago byAutomated external defibrillators (AEDs) can save the lives of individuals suffering from a cardiac arrest event. Sudden cardiac arrest can happen to anyone and at any time. According to the American Red Cross, over 350,000 people will suffer from sudden …
Posted in News
Tagged aeds, american red cross, cardiac emergency, electrode pads, electrodes, FDA, fibrillation, heart rhythms, medical device, shock, sudden cardiac arrest, tachycardia
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RQS Cares – Congenital Heart Walk
Posted 33 days ago by
RQS is happy to announce that RQS Cares is organizing a group for the Congenital Heart Walk event occurring on June 22nd, 2013 in Allison Park, PA. The race serves as a community gathering and fundraising event for ACHA, an organization to …
Posted in Announcements, News, RQS Cares
Tagged acha, chd, children's heart foundation, congenital heart disease, congenital heart walk, fundraising event, heart disease, heart foundation, promising research, RQS
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RQS Cares – Race for the Place
Posted 33 days ago by
RQS is happy to announce that RQS Cares is organizing a group for the Race for the Place 5K run / 1 mile walk event occurring on June 2nd, 2013 in Beachwood, OH. The race serves as a fundraising event for …
Posted in Announcements, News, RQS Cares
Tagged cancer survivor, gathering place, race for the place, registrations, RQS, runners, walkers
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Quality Systems Becoming the Culture of a Company
Posted 37 days ago byThe culture of a company is what drives the organization – it can change and adapt, but ultimately, if a strong management team doesn’t drive a company’s culture – the company risks losing its identity. For medical device companies, establishing a …
Posted in News
Tagged corporate policy, corporate quality, executive management team, management reviews, manufacturing process, medical device companies, quality management, quality manager, quality policy, Quality System
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Crowd Source in Medical Devices?
Posted 38 days ago by
Collaborative development, or for the purposes of this post we’ll call it “crowd sourcing”, seems to be discussed and used more frequently in the current business environment. Obviously, crowd sourced projects have been around for a long while (Wikipedia is …
Posted in News
Tagged ANVISA, crowd source, engineering projects, FDA, HPFB, investors, medical device, medical device companies, medical device industry, money, open source projects, regulatory risk, TGA, wikipedia
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Human Factors
Posted 39 days ago byRecently I had to get my annual mammogram. They were running behind like doctor’s offices sometimes do – there were seven women in dressing gowns in the waiting room with me. After a few awkward moments, we all started to …
Posted in News
Tagged Breast Cancer, breast cancer screening, human factors, mammogram, mammograms, medical device, Medical Devices, quality, regulatory, usability, Women in Bio
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Patent Law Changes
Posted 44 days ago byFor over 200 years, the US has operated under a “first to invent” rule. This means that if two innovators independently submit a patent for the same exact invention, the person who can prove that they invented it first is …
Posted in News
Tagged first to file, first to invent, Innovation, investors, law, medical device, patent, patent application, patent office, patent system, us patent law
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