Gekko Medical has achieved ISO 13485:2016 certification for the design and manufacture of electro-mechanical, pneumatically driven respiratory devices with accessories.
ISO 13485:2016 specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to supply medical devices and related services that consistently meet customer and applicable regulatory requirements. Through a series of independent audits conducted by internationally recognized notified body BSI, Gekko Medical has successfully satisfied the applicable clause requirements. This certification demonstrates the QMS compliance and can be used as evidence to gain regulatory access to international markets for Gekko Medical’s GeVentor GEV019 Ventilator.
Gekko Medical’s successful certification will facilitate a multitude of opportunities for distribution, sales and donations of the GeVentor and provide alternate potential pathways to continually increase revenue growth. These opportunities will come from regions that require ISO 13485:2016 certification for market access.
The Quality Management System was developed and implemented within a short timeline with consideration to the company mission of ‘Using innovation to improve & save lives’. The accreditation audit process was prepared and led by Gekko Medical team in its entirety. Together, the team and our collaborators have developed a Quality Management System that is not only effective but emphasizes safety and efficiency at all levels.
Quote attributed to Andrew Edmondston, CEO
“Achieving ISO-13485 certification is an important milestone to full commercialization of the GeVentor GEV019 Ventilator. The rapid development of the GeVentor, the achievement of the COVID-19 exemption and ISO 13485 certification is a testament to the high-quality team we have at Gekko Medical. We are looking forward to capitalizing on the opportunities this certification will present.”
Quote attributed to Jack Verbeek, General Manager (Acting)
“Gekko Medical has used industry regulations and standards as a base to produce innovative solutions with the patient and user as the centre point. With key stakeholder relationships Gekko Medical is confident in developing and delivery of solutions locally and internationally.”
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