Author Archives: Karen Delaney

About Karen Delaney

Karen is the President of Helix Consulting Group, a quality assurance company offering businesses a comprehensive range of services to ensure regulatory requirement compliance and assist with approvals and licensing for new product development. With dual Bachelors Degrees in Science and Education from Memorial University, Karen continued to launch her career as an entrepreneur with the founding of Helix Consulting Group. For nearly two decades, Karen has delivered expert Quality Assurance services to a broad spectrum of clientele in Vancouver and internationally. Utilizing her foundation of knowledge and experience, Karen not only provides compliance services, but also extends her talents to assist clients in earning FDA, FAA and TCCA approvals, as well as HC licenses and CE Marking.

Five tips for medical device makers seeking FDA approval – entrepreneurship.org

by Frank Vinluan Millions of people use a 510(k) cleared medical device daily without even realizing the product has been evaluated by the U.S. Food and Drug Administration. It’s the toothbrush. The toothbrush is a class I medical device, said … Continue reading

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Helix Consulting Group

Karen is the President of Helix Consulting Group, a quality assurance company offering businesses a comprehensive range of services to ensure regulatory requirement compliance and assist with approvals and licensing for new product development. With dual Bachelors Degrees in Science … Continue reading

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Happy New Year!

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American Society for Quality

I’m a member of the American Society for Quality, check them out at: http://asq.org

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6 Tips for Maintaining FDA Compliance – compliance-insight.com

#1:  See what is causing FDA Compliance issues with other firms.  Keep on top of FDA observations given to other firms.  Evaluate them for comparison to similar operations in your firm. #2:  Seek outside help.  Don’t go it alone to … Continue reading

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5 Ways to Build Your Brand in Short Chunks of Time

By Jayson Demers Your brand embodies everything that you do and stand for as a business. At a tangible level, your business name, tagline, the colors you use and the content you publish encode your brand and present it visually and … Continue reading

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8 Step Process Perfects New Product Development

By Robert F. Brands Every entrepreneur knows that productivity is one of the key ingredients for successful product development. One of the two key processes in Robert’s Rules of Innovation is the NEW PRODUCT DEVELOPMENT PROCESS. A formalized, NPD process – also referred … Continue reading

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