14 May ABLE Human Motion obtained ISO13485 Certification
After months of intense and hard work of our team, ABLE Human Motion, S.L. obtained the Quality Management System (QMS) certification according to ISO 13485 for the design, manufacture and sales of wearable powered exoskeletons. As a certification entity, we chose BSI (British Standards Institution), who pioneered standards over 100 years and are the current market leader.
ISO 13485:2016 specifies the requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
With the implementation of a QMS according to ISO 13485, we commit to continuous improvement and we demonstrate that we are able to produce safe, high quality and top performance medical devices that aim to improve the efficiency of rehabilitation and promote patient’s reintegration into the community.
“The ISO13485 certification is an important step to achieve high levels of efficiency and quality of our products, providing high customer and patient satisfaction. We strive for excellence, every detail and every opinion always matters. And continuous improvement is the only way.” Alfons Carnicero, CEO at ABLE Human Motion.
ISO13485 constitutes a valuable management tool through the entire product life-cycle, from early stages of product conceptualization and development to manufacturing and post-market activities. We have conceived our QMS in a way that we can maintain our agile and innovative nature.
Having a QMS in place will allow us to add value to our end-users, both patients and clinical professionals, by meeting regulatory requirements and customer expectations.
With the accomplishment of this huge milestone, we are one step closer to the certification of our first product, the ABLE Exoskeleton. ISO 13485 is the best internationally accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485 is the QMS standard accepted as the basis for CE marking medical devices under European Regulation MDR 2017/745 as it remains a state-of-the-art document.
Finally, we want to thank the certification entity that has granted the certification, BSI, with whom we share a mission to make excellence a habit. This is underpinned by their role as the national standards body and through their prestigious Royal Charter.