QUALITY

Our aims and quality objectives are clear and simple. To design, develop and manufacture high quality medical devices in compliance with ISO 13485:2016, all UK and European regulations and FDA requirements, in the medical specialisms of anaesthesiology, gastroenterology, critical care and airway management.

In order to achieve this, Medovate works closely with carefully selected partners and we continually strive to improve our processes and products to meet customer, quality and regulatory requirements.

Medovate is an ISO 13485: 2016 certified company.

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.

* 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.