Medovate, the medical device company, has today announced it has achieved ISO 13485:2016* quality management system certification.
The certification confirms that Medovate operates an internationally recognised quality management system for the control of design, development, manufacture, installation and servicing of medical devices. Certification was awarded following a series of rigorous independent audits in accordance with ISO 13485:2016 regulatory requirements.
Medovate’s certification enables it to develop and bring to market products relating to its priority medical specialisms of anaesthesia, intensive and critical care, and surgery. Specifically, the company has received accreditation in regional anaesthesia systems, endoscopic instruments and wound therapy devices and blood sampling devices, and for the areas of anaesthesiology, gastroenterology, critical care and airway management.
Alan Finnerty, Technology Development Manager, Medovate, commented: “Achieving certification is an important milestone for Medovate and establishes us as a credible player in the medtech innovation world. Our aim is to help medical device innovators progress their products from concept all the way through testing and regulatory approval to market launch. Being officially recognised as ISO 13485 certified means the clinical innovators we work with, the healthcare providers that use the products and ultimately the patients that benefit from improved outcomes can rest assured that our portfolio is being designed, developed and manufactured in compliance with the most stringent quality and regulatory standards.”
* International Organization for Standardization ISO 13485:2016 is an internationally recognised standard which sets the requirements of the Quality Management System (QMS) for the full range of operations of medical device companies.