About

The Innovator

Dr. Magdy Younes, MD, FRCPC, PhD

Dr. Younes is a world-renowned respiratory specialist and innovator. He is a Distinguished Professor Emeritus at the University of Manitoba in Winnipeg, Canada as well as a Senior Scholar in its Faculty of Medicine. He is also a research professor at the University of Calgary Faculty of Medicine.

Dr. Younes received his MD from the University of Alexandria in Egypt and went on to train in internal medicine and respirology at McGill University in Montreal, where he also obtained a PhD specializing in pulmonary physiology. He established the sleep laboratory at the Health Sciences Centre in Winnipeg in 1991 and was its director until he retired from active practice.

Dr. Younes has done extensive research in the areas of respirology and respiratory physiology including topics such as reflex control of breathing, control of breathing during exercise, the pathogenesis of respiratory failure, and sleep apnea. His research has resulted in 118 original peer-reviewed papers and 22 book chapters and reviews. His work, specifically on sleep apnea, has appeared in 19 influential peer-reviewed publications on the pathogenesis of the disorder. Dr. Younes was recently invited to write the chapter on sleep apnea in the authoritative Comprehensive Physiology (formerly the Handbook of Physiology), published by the American Physiological Society.

A medical innovator from the beginning of his career, the development of the automatic sleep scoring system (Michele) is the latest in a series of inventions by Dr. Younes. These include proportional assist ventilation (PAV), mechanical ventilator design, and several methods for non-invasive determination of respiratory mechanics and monitoring of respiratory muscle pressure output in patients on mechanical ventilation. His inventions in the area of mechanical ventilation have been incorporated in several commercial ventilators used throughout the world.


The Collaborator and Namesake

Ms. Michele Ostrowski, R.PSG.T

Ms. Ostrowski is a registered polysomnography technologist who trained in Winnipeg, Canada. She has been active in the sleep technology industry since 1990 and has worked in both private and academic laboratories. In addition to serving as chief technologist at both Winnipeg’s Health Sciences Centre and Calgary’s Foothills Medical Centre, Ms. Ostrowski has extensive experience in all aspects of sleep technology, and is co-author on several research publications.

The software component of the Michele Sleep Scoring System has been designed and validated using Ms. Ostrowski’s scoring of sleep records. She has participated extensively in developing the user manual and viewer features for the software to make sure the user experience is as effortless and practical as possible, simulating a “real-world” clinic setting.


Quality Management System

Cerebra Medical operates a Quality Management System for the design, development and manufacture of EEG sleep monitoring systems and medical device software for analysis of physiological data recorded during sleep.

Cerebra Medical’s QMS complies with the requirements of ISO 13485:2016, Health Canada Medical Device Regulations SOR 98/282, European Union Medical Device Directives, and FDA’s 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D.

Cerebra Medical is committed to continual improvement of its products and Quality Management System.

Certification

Cerebra Medical holds MDSAP Certificate No. MDSAP 689837, conforming to requirements of USA and Canada, as well as ISO 13485:2016 Certificate Number FM 551942.

Under the supervision of BSI, a Notified Body (2797), Cerebra Medical is in conformance with the provisions of Annex V/Annex VII and of the Essential Requirements of Annex I of the European Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC, holding EC Certificate CE 552637.

The Michele Sleep Scoring system has received market clearance in Canada, the European Union and the United States of America. The Prodigy Sleep Monitor, Prodigy Sleep System, and Prodigy DSA have received market clearance in Canada.

To obtain further information on Cerebra Medical’s Quality Management System or any regulatory matters, please contact Brittany Gibson, Director of Quality and Regulatory Affairs for Cerebra Medical.

P 204 949 3200

E brittany.gibson@cerebrahealth.com