For our penultimate edition of Everyday Usability, we take a look into what the future of Usability could look like. What better way to improve usability than to remove the physical interface altogether and implementing voice control of medical devices? …
The purpose of this position is to provide comprehensive quality and regulatory leadership to medical device companies. The successful candidate will be able to perform the following for customers, while always ensuring business-focused decision making: 1) Responsible for business development …
Good morning, Recent changes within the FDA’s 510(k) program have left many companies in a state of confusion and at times downright frustration. Join us on November 9 as the Council hosts Heather Rosecrans, Senior Regulatory Advisor, Greenleaf Health LLC …
Regulatory & Quality Solutions is seeking a Senior Regulatory and Quality Engineer for our team. This position will provide comprehensive regulatory and quality solutions to clients with the introduction, advancement and/or maintenance of their market positions or growth in their …
Regulatory & Quality Solutions is seeking a Principal Regulatory and Quality Engineer for our team. This position will provide comprehensive quality and regulatory leadership to Pittsburgh medical device companies. The successful candidate will be able to perform the following for customers, …
Good morning blog folks! I greet you this morning with a familiar topic from the early part of this usability series: Colors! (or “Colours!” for those of our readers who favour the use of “u” in said words). This time …
Biotech’s slow coup of the mobile industry never ceases to amaze me. In this latest piece of news, the addition of a simple (and cheap) ball lens to the iPhone camera creates a microscope strong enough to view details at …
As some who know me would tell you, my mind happens to wander at times about a variety of topics. The subject of this mental galavant happened to be the current regulatory landscape in the United States – specifically the …
A great example of usability engineering is right in front of us every day (especially as we become a more technological society): electrical outlets! What a simple fix to ensure that electrical plugs are inserted properly into the electrical outlets …
When designing medical devices it is important to identify use-related hazards as early in development as possible so that mitigations can be developed into user interface requirements, incorporated into the design, and then tested for effectiveness. The recently released draft …
Regulatory and Quality Solutions LLC
3919 William Penn Highway
Suite 200
Murrysville, PA 15668
Phone: (724) 327-0230
rmarkley@raqasolutions.com
