Rhythmlink International has received Health Canada Medical Device License for Disposable Subdermal Needle Electrodes and EEG Electrodes and is expected to market and sell the products in Canada.
Rhythmlink said that the license has been granted in accordance with the Medical Device Regulations, Section 36, of Health Canada’s Therapeutic Products Directorate.
Rhythmlink’s quality management system, which oversees the design and development of all of its medical products and accessories, met the requirements of the International Organization for Standardization [ISO] 13485:2003 standards earlier this year. The certification has opened the door for Rhythmlink to receive CE Markings and Medical Device Licenses from Canada.
Jim Mewborne, director of engineering and regulatory affairs of Rhythmlink, said: “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.”
Columbia-based Rhythmlink International designs, manufactures and distributes neurodiagnostic accessories and provides custom packaging, private labeling and OEM solutions to its customers.