As of April 13, 2010, Rhythmlink International has been granted its Health Canada Medical Device License and will now market and sell product in Canada. In accordance with the Medical Device Regulations, Section 36, of Health Canada's Therapeutic Products Directorate, Rhythmlink's Disposable Subdermal Needle Electrodes and EEG Electrodes both received individual licenses for their families of products.
"Obtaining our Medical Device License from Health Canada is a great addition as we continue to expand into new markets and offer new services. We strive for a high degree of core competencies in every area, from design through product distribution, and this is another example of the character and commitment of everyone at Rhythmlink," said Jim Mewborne, Rhythmlink's director of engineering and regulatory affairs.
Rhythmlink's Quality Management System, which oversees the design and development of all of Rhythmlink's medical products and accessories, met the requirements of the International Organization for Standardization [ISO] 13485:2003 standards earlier this year. This certification is an internationally recognized management system standard developed by ISO and opened the door for Rhythmlink to receive CE Markings and Medical Device Licenses from Canada.