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.
Monthly Archives: March 2015
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