Class II – IV Medical Device Investigational Testing in Canada

Publication date: April 2014 / Download as PDF Author: Ibtissem Triki Canadian Medical Device Classifications The Food and Drugs Act (1) defines a “device” as any article, instrument, apparatus or contrivance, including any component, part of accessory thereof, manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state. It includes a vast range of equipment, from a simple tongue depressor to roboti...
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Vantage BioTrials Launches Whitepaper Initiative

April 2, 2014, Montréal, Canada – As part of Vantage BioTrials’ continued focus and dedication in providing superior clinical trial management services to the pharmaceutical industry, we are excited to launch and share with our Sponsors, industry professionals and employees our own White Paper. As part of our commitment, Vantage BioTrials’ White Paper will serve to share as an informational resource to give our readers a more detailed look at specific areas of the pharmaceutical/clinical...
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VBT’s Medical Device Sponsor Announces FDA 510(k) Clearance of Proprietary Needle Guidance System for Lung Interventions

July 13, 2011, Montreal, Canada – One of Vantage BioTrials’ early stage medical device sponsors (pioneering the development of cost-effective interventional medical navigation instrumentation), announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its flagship product, a Proprietary Needle Guidance System, for lung interventions. Vantage BioTrials’ Project Management and Clinical Monitoring teams were instrumental in setting up and mana...
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Vantage BioTrials Undergoes a Series of Successful Client Audits

February 23, 2011, Montréal, Canada – After 5 years of operations and growth, Vantage BioTrials has successfully concluded four client audits of their systems, SOPs and Good Clinical Practices. The audits occurred over a span of 2 months and each resulted in minor findings. All Sponsor comments, feedbacks and observations were addressed and resolved. “We always remain open to constructive feedback from our clients and dedicated to the highest expectations of quality in the delivery of our s...
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