ABM Respiratory Care, a medical technology company focused on developing and globally commercializing novel integrated airway clearance and ventilation solutions, announced today it has received CE marking for their BiWaze® Cough system in accordance with European Union’s Medical Device Regulation (MDR) 2017/745.
The EU MDR is the set of regulations that governs the worldwide production and European distribution of medical devices. Compliance with this regulation is mandatory by registering bodies for medical device companies to legally market and sell their products in the EEA (European Economic Area). As part of the new MDR regulations, all manufacturers of medical devices for sale within the EU must adhere to more strict guidelines to ensure their products are safe to use. We are proud to be one of the few companies in the Respiratory market to have met these stringent requirements.
The innovative BiWaze Cough system offers unique airway clearance therapy to help people who are unable to cough productively. Obtaining the CE certification mark allows BiWaze Cough to be available in hospitals, homes and long- term care facilities across Europe, and positions the company on a path ultimately leading to offering a complete respiratory care solution to the European market. BiWaze Cough has been designed, manufactured, and tested in accordance with International Organization for Standards (ISO) 13485 standard and US FDA compliant quality processes. These certifications endorse the quality and safety of ABM Respiratory Care’s products to treat people with acute and long- term lung conditions.
“The entire team collaborated on this tremendous achievement to ensure the BiWaze Cough manufacturing, quality, and product performance meets the new medical device regulation requirements. Obtaining CE mark certification during these challenging times is a testament to the strength, experience and determination of the team,” said Vinay Joshi, CEO, ABM Respiratory Care. “This certification will enable us to commercialize in Europe and provide our innovative cough therapy solution to the people who need it. We believe our respiratory solutions have the potential to meaningfully improve health outcomes and quality of life for people around the world.”
